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Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (PACIFIC-AMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304534
Recruitment Status : Completed
First Posted : March 11, 2020
Results First Posted : April 5, 2023
Last Update Posted : April 5, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Myocardial Infarction
Interventions Drug: BAY2433334
Other: BAY2433334 matching placebo
Enrollment 1601
Recruitment Details Study was conducted at 157 centers in 14 countries or regions, between 17-Jun-2020 (first participant first visit) and 21-Feb-2022 (last participant last visit)
Pre-assignment Details 1664 participants were screened, 63 participants were screening failures. 1601 participants were randomized in a 1:1:1:1 ratio to 4 treatment groups: 397, 401, and 402 participants to the asundexian 10 mg, 20 mg and 50 mg groups and 401 participants to the placebo group
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description Participants received Asundexian (BAY2433334) 10 mg Participants received Asundexian (BAY2433334) 20 mg Participants received Asundexian (BAY2433334) 50 mg Participants received placebo
Period Title: Overall Study
Started [1] 397 401 402 401
Treated [2] 395 397 402 399
Completed 303 [3] 317 [3] 309 [3] 309 [3]
Not Completed 94 84 93 92
Reason Not Completed
Subject decision COVID-19 pandemic related             1             0             1             0
Non-Compliance with study drug             0             1             1             1
Lost to Follow-up             0             1             2             3
Unspecific             4             2             2             2
Technical Problems             2             2             3             4
Death             7             2             4             3
Withdrawal by Subject             7             2             7             4
Physician Decision             4             9             9             5
Subject Decision             34             25             25             26
Adverse Event             35             40             39             44
[1]
Full analysis set (FAS)
[2]
Safety analysis set (SAF)
[3]
Treatment completed
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo Total
Hide Arm/Group Description Participants received Asundexian (BAY2433334) 10 mg Participants received Asundexian (BAY2433334) 20 mg Participants received Asundexian (BAY2433334) 50 mg Participants received placebo Total of all reporting groups
Overall Number of Baseline Participants 397 401 402 401 1601
Hide Baseline Analysis Population Description
FAS(Full data analysis)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 401 participants 402 participants 401 participants 1601 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
122
  30.7%
123
  30.7%
118
  29.4%
136
  33.9%
499
  31.2%
>=65 years
275
  69.3%
278
  69.3%
284
  70.6%
265
  66.1%
1102
  68.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 401 participants 402 participants 401 participants 1601 participants
Female
93
  23.4%
87
  21.7%
100
  24.9%
90
  22.4%
370
  23.1%
Male
304
  76.6%
314
  78.3%
302
  75.1%
311
  77.6%
1231
  76.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 401 participants 402 participants 401 participants 1601 participants
American Indian or Alaska Native
1
   0.3%
2
   0.5%
0
   0.0%
0
   0.0%
3
   0.2%
Asian
53
  13.4%
50
  12.5%
50
  12.4%
50
  12.5%
203
  12.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   0.8%
2
   0.5%
2
   0.5%
1
   0.2%
8
   0.5%
White
334
  84.1%
345
  86.0%
347
  86.3%
339
  84.5%
1365
  85.3%
More than one race
1
   0.3%
0
   0.0%
2
   0.5%
2
   0.5%
5
   0.3%
Unknown or Not Reported
5
   1.3%
2
   0.5%
1
   0.2%
9
   2.2%
17
   1.1%
1.Primary Outcome
Title Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)
Hide Description

CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.

Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.

Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.

ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 397 401 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
27
   6.8%
24
   6.0%
22
   5.5%
22
   5.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Statistical Test of Hypothesis P-Value = 0.8439
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.052
Confidence Interval (2-Sided) 90%
0.687 to 1.612
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Placebo
Comments Comparison of the Asundexian 20 mg group versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Statistical Test of Hypothesis P-Value = 0.7562
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.096
Confidence Interval (2-Sided) 90%
0.674 to 1.781
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Statistical Test of Hypothesis P-Value = 0.978
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.008
Confidence Interval (2-Sided) 90%
0.614 to 1.656
Estimation Comments [Not Specified]
2.Primary Outcome
Title Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5
Hide Description Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SAF
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo Pooled Asundexian
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Overall Number of Participants Analyzed 395 397 402 399 1194
Measure Type: Count of Participants
Unit of Measure: Participants
30
   7.6%
32
   8.1%
42
  10.4%
36
   9.0%
104
   8.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled Asundexian
Comments Comparison of the Pooled Asundexian group versus Placebo group
Type of Statistical Test Other
Comments HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.
Statistical Test of Hypothesis P-Value = 0.9158
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.713 to 1.347
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asundexian 10 mg, Placebo
Comments Comparison of the Asundexian 10 mg group versus Placebo group
Type of Statistical Test Other
Comments HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.
Statistical Test of Hypothesis P-Value = 0.5633
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.867
Confidence Interval (2-Sided) 90%
0.577 to 1.302
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Placebo
Comments Comparison of the Asundexian 20 mg group versus Placebo group
Type of Statistical Test Other
Comments HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.
Statistical Test of Hypothesis P-Value = 0.584
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.875
Confidence Interval (2-Sided) 90%
0.587 to 1.306
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.
Statistical Test of Hypothesis P-Value = 0.417
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.202
Confidence Interval (2-Sided) 90%
0.828 to 1.747
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Efficacy - Number of Participants With CV Death
Hide Description CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 397 401 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
7
   1.8%
4
   1.0%
5
   1.2%
2
   0.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.275
Confidence Interval (2-Sided) 90%
0.322 to 5.050
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.991
Confidence Interval (2-Sided) 90%
0.479 to 8.273
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Efficacy - Number of Participants With MI
Hide Description Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 397 401 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
18
   4.5%
20
   5.0%
18
   4.5%
17
   4.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.125
Confidence Interval (2-Sided) 90%
0.696 to 1.819
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Placebo
Comments Comparison of the Asundexian 20 mg group versus Placebo group
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.181
Confidence Interval (2-Sided) 90%
0.686 to 2.031
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.070
Confidence Interval (2-Sided) 90%
0.613 to 1.866
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Efficacy - Number of Participants With Stroke
Hide Description Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 397 401 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.0%
3
   0.7%
0
   0.0%
2
   0.5%
6.Secondary Outcome
Title Efficacy - Number of Participants With Stent Thrombosis
Hide Description ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 397 401 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.0%
5
   1.2%
4
   1.0%
4
   1.0%
7.Secondary Outcome
Title Efficacy - Number of Participants With All Cause Mortality
Hide Description [Not Specified]
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 397 401 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
10
   2.5%
7
   1.7%
10
   2.5%
7
   1.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments For all-cause mortality there is no competing event.
Statistical Test of Hypothesis P-Value = 0.6016
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.266
Confidence Interval (2-Sided) 90%
0.603 to 2.658
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asundexian 20 mg, Placebo
Comments Comparison of the Asundexian 20 mg group versus Placebo group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.9945
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.996
Confidence Interval (2-Sided) 90%
0.414 to 2.401
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asundexian 50 mg, Placebo
Comments Comparison of the Asundexian 50 mg group versus Placebo group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.4085
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.506
Confidence Interval (2-Sided) 90%
0.667 to 3.405
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Safety - Number of Participants With All Bleeding
Hide Description All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SAF
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 395 397 402 399
Measure Type: Count of Participants
Unit of Measure: Participants
70
  17.7%
75
  18.9%
82
  20.4%
85
  21.3%
9.Secondary Outcome
Title Safety - Number of Participants With BARC Bleeding Definition Type 3, 5
Hide Description Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SAF
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 395 397 402 399
Measure Type: Count of Participants
Unit of Measure: Participants
5
   1.3%
3
   0.8%
3
   0.7%
5
   1.3%
10.Secondary Outcome
Title Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5
Hide Description Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.
Time Frame From baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SAF
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description:
Participants received Asundexian (BAY2433334) 10 mg
Participants received Asundexian (BAY2433334) 20 mg
Participants received Asundexian (BAY2433334) 50 mg
Participants received placebo
Overall Number of Participants Analyzed 395 397 402 399
Measure Type: Count of Participants
Unit of Measure: Participants
70
  17.7%
75
  18.9%
82
  20.4%
85
  21.3%
Time Frame After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Hide Arm/Group Description Subjects received Asundexian (BAY2433334) 10 mg for 26 weeks at least and up to 52 weeks Subjects received Asundexian (BAY2433334) 20 mg for 26 weeks at least and up to 52 weeks Subjects received Asundexian (BAY2433334) 50 mg for 26 weeks at least and up to 52 weeks Subjects received Asundexian (BAY2433334) placebo for 26 weeks at least and up to 52 weeks
All-Cause Mortality
Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/397 (2.52%)      7/401 (1.75%)      10/402 (2.49%)      7/401 (1.75%)    
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Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/395 (18.73%)      82/397 (20.65%)      67/402 (16.67%)      82/399 (20.55%)    
Blood and lymphatic system disorders         
Anaemia * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Cardiac disorders         
Acute myocardial infarction * 1  9/395 (2.28%)  9 9/397 (2.27%)  12 10/402 (2.49%)  11 8/399 (2.01%)  8
Angina pectoris * 1  5/395 (1.27%)  5 4/397 (1.01%)  4 6/402 (1.49%)  6 1/399 (0.25%)  1
Angina unstable * 1  4/395 (1.01%)  4 1/397 (0.25%)  1 2/402 (0.50%)  2 4/399 (1.00%)  6
Atrial fibrillation * 1  1/395 (0.25%)  1 2/397 (0.50%)  2 1/402 (0.25%)  1 2/399 (0.50%)  2
Atrioventricular block complete * 1  0/395 (0.00%)  0 2/397 (0.50%)  2 0/402 (0.00%)  0 1/399 (0.25%)  1
Atrioventricular block second degree * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Cardiac arrest * 1  3/395 (0.76%)  3 1/397 (0.25%)  1 1/402 (0.25%)  1 1/399 (0.25%)  1
Cardiac failure * 1  3/395 (0.76%)  5 4/397 (1.01%)  5 2/402 (0.50%)  2 5/399 (1.25%)  6
Cardiac failure acute * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 1/402 (0.25%)  1 0/399 (0.00%)  0
Cardiac failure chronic * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  2
Cardiac failure congestive * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Cardiac tamponade * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Cardiogenic shock * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 1/402 (0.25%)  1 0/399 (0.00%)  0
Coronary artery disease * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 1/402 (0.25%)  1 0/399 (0.00%)  0
Coronary artery embolism * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Coronary artery stenosis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Coronary artery thrombosis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Dressler's syndrome * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Interventricular septum rupture * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Mitral valve incompetence * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Myocardial infarction * 1  2/395 (0.51%)  2 2/397 (0.50%)  2 3/402 (0.75%)  3 3/399 (0.75%)  3
Myocardial ischaemia * 1  1/395 (0.25%)  1 2/397 (0.50%)  2 1/402 (0.25%)  1 0/399 (0.00%)  0
Palpitations * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Pericardial effusion * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Supraventricular tachycardia * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Ventricular fibrillation * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 2/399 (0.50%)  2
Ventricular tachycardia * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Intracardiac thrombus * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Coronary artery dissection * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Cardiopulmonary failure * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Acute coronary syndrome * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 3/399 (0.75%)  3
Cardiac ventricular thrombosis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 1/399 (0.25%)  1
Coronary artery perforation * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Stress cardiomyopathy * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Sinus node dysfunction * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Ear and labyrinth disorders         
Vertigo * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain upper * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Colitis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Colitis ulcerative * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Diarrhoea * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Gastritis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Haematemesis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Haematochezia * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Intestinal obstruction * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Melaena * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 1/402 (0.25%)  1 0/399 (0.00%)  0
Pancreatitis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Pancreatitis chronic * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Proctalgia * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Rectal haemorrhage * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Rectal ulcer haemorrhage * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Upper gastrointestinal haemorrhage * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Vomiting * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Mechanical ileus * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Gastric antral vascular ectasia * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Large intestine polyp * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
General disorders         
Asthenia * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Chest discomfort * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Chest pain * 1  4/395 (1.01%)  4 5/397 (1.26%)  5 4/402 (1.00%)  4 4/399 (1.00%)  4
Death * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Malaise * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Pyrexia * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Inflammation * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Non-cardiac chest pain * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Vascular stent thrombosis * 1  1/395 (0.25%)  1 1/397 (0.25%)  2 0/402 (0.00%)  0 2/399 (0.50%)  2
Vascular stent stenosis * 1  2/395 (0.51%)  2 2/397 (0.50%)  3 1/402 (0.25%)  1 2/399 (0.50%)  3
Hepatobiliary disorders         
Bile duct stone * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Cholecystitis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Cholecystitis acute * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Hepatic function abnormal * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Hepatitis toxic * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Ischaemic hepatitis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Portal hypertension * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Infections and infestations         
Appendicitis * 1  3/395 (0.76%)  3 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Cystitis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Diverticulitis * 1  0/395 (0.00%)  0 2/397 (0.50%)  3 0/402 (0.00%)  0 1/399 (0.25%)  1
Diverticulitis intestinal haemorrhagic * 1  1/395 (0.25%)  2 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Erysipelas * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Gastroenteritis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 2/402 (0.50%)  2 0/399 (0.00%)  0
Pneumonia * 1  2/395 (0.51%)  2 1/397 (0.25%)  1 1/402 (0.25%)  1 0/399 (0.00%)  0
Pneumonia aspiration * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Sepsis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Urinary tract infection * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 1/402 (0.25%)  1 1/399 (0.25%)  1
Urinary tract infection bacterial * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Clostridium difficile infection * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Respiratory tract infection * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Acarodermatitis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
COVID-19 * 1  1/395 (0.25%)  1 1/397 (0.25%)  2 7/402 (1.74%)  7 5/399 (1.25%)  5
COVID-19 pneumonia * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 1/402 (0.25%)  1 4/399 (1.00%)  4
Injury, poisoning and procedural complications         
Femoral neck fracture * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Head injury * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Road traffic accident * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Subdural haematoma * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Vaccination complication * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Contusion * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Urinary retention postoperative * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Periprocedural myocardial infarction * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Investigations         
Coagulation factor VIII level increased * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Haemoglobin decreased * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Arterial bruit * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Hepatic enzyme increased * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Von Willebrand's factor antigen increased * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Von Willebrand's factor activity increased * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Metabolism and nutrition disorders         
Diabetes mellitus * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Hyperkalaemia * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Hypoglycaemia * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Decreased appetite * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Lumbar spinal stenosis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Osteoarthritis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Rhabdomyolysis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Tenosynovitis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Intervertebral disc protrusion * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma gastric * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Bladder neoplasm * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Bronchial carcinoma * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Lymphoma * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Malignant melanoma * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Non-Hodgkin's lymphoma * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Pancreatic carcinoma * 1  2/395 (0.51%)  2 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Tongue neoplasm malignant stage unspecified * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Transitional cell carcinoma * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Urethral cancer * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Tumour haemorrhage * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 1/402 (0.25%)  1 0/399 (0.00%)  0
Prostate cancer * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Pancreatic neoplasm * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Nervous system disorders         
Altered state of consciousness * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Ataxia * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Cerebral haemorrhage * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Cerebral infarction * 1  2/395 (0.51%)  2 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Cerebrovascular accident * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 1/402 (0.25%)  1 1/399 (0.25%)  1
Dizziness * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Dizziness postural * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Myelitis transverse * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Sciatica * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Syncope * 1  2/395 (0.51%)  2 2/397 (0.50%)  2 2/402 (0.50%)  2 0/399 (0.00%)  0
Transient ischaemic attack * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Spinal epidural haematoma * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Ischaemic cerebral infarction * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Ischaemic stroke * 1  2/395 (0.51%)  2 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Metabolic encephalopathy * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Hypoxic-ischaemic encephalopathy * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Renal and urinary disorders         
Haematuria * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  2 0/399 (0.00%)  0
Nephrolithiasis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Renal artery stenosis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Renal colic * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Urinary retention * 1  0/395 (0.00%)  0 2/397 (0.50%)  2 0/402 (0.00%)  0 1/399 (0.25%)  1
Renal impairment * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 2/402 (0.50%)  2 1/399 (0.25%)  1
Acute kidney injury * 1  2/395 (0.51%)  2 2/397 (0.50%)  2 2/402 (0.50%)  2 0/399 (0.00%)  0
Ureterolithiasis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Reproductive system and breast disorders         
Prostatitis * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Uterine polyp * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 2/399 (0.50%)  2
Bronchitis chronic * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Chronic obstructive pulmonary disease * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 1/399 (0.25%)  1
Dyspnoea * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 1/402 (0.25%)  1 3/399 (0.75%)  3
Epistaxis * 1  1/395 (0.25%)  1 1/397 (0.25%)  4 0/402 (0.00%)  0 0/399 (0.00%)  0
Hyperventilation * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Pleural effusion * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Pulmonary embolism * 1  0/395 (0.00%)  0 2/397 (0.50%)  2 1/402 (0.25%)  1 0/399 (0.00%)  0
Pulmonary fibrosis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 2/399 (0.50%)  2
Pulmonary hypertension * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Pulmonary oedema * 1  2/395 (0.51%)  2 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Respiratory failure * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Skin and subcutaneous tissue disorders         
Angioedema * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Henoch-Schonlein purpura * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Diabetic foot * 1  2/395 (0.51%)  3 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Surgical and medical procedures         
Coronary arterial stent insertion * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Transurethral bladder resection * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Polypectomy * 1  0/395 (0.00%)  0 1/397 (0.25%)  1 0/402 (0.00%)  0 0/399 (0.00%)  0
Sigmoidectomy * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Cardiac resynchronisation therapy * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Percutaneous coronary intervention * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Revascularisation procedure * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Vascular disorders         
Aortic stenosis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Arterial rupture * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Giant cell arteritis * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Haematoma * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 0/402 (0.00%)  0 1/399 (0.25%)  1
Hypertension * 1  1/395 (0.25%)  1 1/397 (0.25%)  1 0/402 (0.00%)  0 1/399 (0.25%)  1
Shock * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
Vascular stenosis * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Hypertensive urgency * 1  1/395 (0.25%)  1 0/397 (0.00%)  0 0/402 (0.00%)  0 0/399 (0.00%)  0
Peripheral arterial occlusive disease * 1  0/395 (0.00%)  0 0/397 (0.00%)  0 1/402 (0.25%)  1 0/399 (0.00%)  0
1
Term from vocabulary, MedDRA (24.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Asundexian 10 mg Asundexian 20 mg Asundexian 50 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/395 (22.53%)      118/397 (29.72%)      94/402 (23.38%)      107/399 (26.82%)    
Gastrointestinal disorders         
Diarrhoea * 1  22/395 (5.57%)  23 21/397 (5.29%)  22 22/402 (5.47%)  25 18/399 (4.51%)  19
General disorders         
Chest pain * 1  13/395 (3.29%)  15 29/397 (7.30%)  32 15/402 (3.73%)  15 17/399 (4.26%)  20
Nervous system disorders         
Dizziness * 1  18/395 (4.56%)  19 19/397 (4.79%)  22 21/402 (5.22%)  22 19/399 (4.76%)  22
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  21/395 (5.32%)  21 27/397 (6.80%)  28 21/402 (5.22%)  23 23/399 (5.76%)  25
Epistaxis * 1  17/395 (4.30%)  25 19/397 (4.79%)  45 21/402 (5.22%)  29 20/399 (5.01%)  26
Vascular disorders         
Hypertension * 1  22/395 (5.57%)  23 27/397 (6.80%)  29 15/402 (3.73%)  15 30/399 (7.52%)  30
1
Term from vocabulary, MedDRA (24.1)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Contracts Partners shall ensure that all patentable Results made by employees of Center or other parties involved by Contract Partners in connection with the performance of the Study, will be notified to Bayer without delay.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer AG
Phone: (+) 1-888-8422937
EMail: clinical-trials-contact@bayer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04304534    
Other Study ID Numbers: 20603
2019-003244-79 ( EudraCT Number )
First Submitted: March 8, 2020
First Posted: March 11, 2020
Results First Submitted: February 19, 2023
Results First Posted: April 5, 2023
Last Update Posted: April 5, 2023