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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

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ClinicalTrials.gov Identifier: NCT02104947
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : August 18, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemorrhage
Intervention Drug: idarucizumab
Enrollment 503

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B)
Hide Arm/Group Description Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes. Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Period Title: Overall Study
Started 301 202
Completed 222 146
Not Completed 79 56
Reason Not Completed
Withdrawal by Subject             10             3
Lost to Follow-up             4             4
Protocol Violation             6             8
Adverse Event             57             38
Other than stated above             2             3
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B) Total
Hide Arm/Group Description Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes. Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes. Total of all reporting groups
Overall Number of Baseline Participants 301 202 503
Hide Baseline Analysis Population Description
Treated set: Treated Set is defined as all patients who were administered idarucizumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 202 participants 503 participants
77.1  (10.4) 75.9  (10.5) 76.6  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 202 participants 503 participants
Female
129
  42.9%
100
  49.5%
229
  45.5%
Male
172
  57.1%
102
  50.5%
274
  54.5%
1.Primary Outcome
Title Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
Hide Description

Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.

Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).

Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.

Time Frame from the end of the first infusion up to 4 hours after the last infusion on Day 1
Show Outcome Measure DataHide Outcome Measure Data
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Treated Set
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B)
Hide Arm/Group Description:
Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Overall Number of Participants Analyzed 301 202
Median (95% Confidence Interval)
Unit of Measure: percentage
dTT (# patients evaluable for reversal=244; 152)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
ECT (# patients evaluable for reversal=276; 185)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
2.Secondary Outcome
Title Reversal of aPTT and TT From Central Laboratory
Hide Description

Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).

Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.

Time Frame from the end of the first infusion up to 4 hours after the last infusion on Day 1
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Hide Analysis Population Description
Treated Set
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B)
Hide Arm/Group Description:
Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Overall Number of Participants Analyzed 301 202
Median (95% Confidence Interval)
Unit of Measure: percentage
aPTT (# patients evaluable for reversal=232; 141)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
TT (# patients evaluable for reversal=278; 188)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
3.Secondary Outcome
Title Duration of Reversal
Hide Description Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Time Frame from the first infusion up to 24 hours after the last infusion on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B)
Hide Arm/Group Description:
Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Overall Number of Participants Analyzed 301 202
Mean (Standard Deviation)
Unit of Measure: hours
ECT (# patients evaluable for reversal=276; 185) 13.2  (10.0) 12.8  (9.7)
dTT (# patients evaluable for reversal=244; 152) 19.8  (6.7) 18.8  (7.6)
4.Secondary Outcome
Title Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively
Hide Description Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
Time Frame within 24 hours of surgery
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Hide Analysis Population Description
Treated Set
Arm/Group Title Idarucizumab (Group B)
Hide Arm/Group Description:
Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Overall Number of Participants Analyzed 202
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.0
(1.1 to 6.5)
5.Secondary Outcome
Title Time to Cessation of Bleeding (for Group A Only)
Hide Description Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Time Frame from the first infusion up to 24 hours after the last infusion on Day 1
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Hide Analysis Population Description
Treated set with patients who stopped bleeding within 24 hours
Arm/Group Title ICH (Group A) Non-ICH (Group A)
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Group A patients with baseline intracranial hemorrhage (ICH).
Group A patients with baseline non-intracranial hemorrhage (non-ICH).
Overall Number of Participants Analyzed 41 134
Median (95% Confidence Interval)
Unit of Measure: hours
10.73
(4.80 to 15.73)
2.49
(2.18 to 3.93)
6.Secondary Outcome
Title Cmin,1 of Unbound Sum (Free) Dabigatran
Hide Description Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
Time Frame Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial
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Hide Analysis Population Description
The Pharmacokinetic Set (PKS): This analysis set was used for all PK analyses and was defined as all patients in the Treated Set who provided at least one PK data point.
Arm/Group Title Idarucizumab (Group A & B)
Hide Arm/Group Description:

In Group A the patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.

In Group B the patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.

Overall Number of Participants Analyzed 493
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.12
(61.2%)
7.Secondary Outcome
Title Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial
Hide Description

Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.

Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.

Time Frame after the first vial of idarucizumab and before the start of second vial on Day1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B)
Hide Arm/Group Description:
Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Overall Number of Participants Analyzed 301 202
Median (95% Confidence Interval)
Unit of Measure: percentage
dTT (# patients evaluable for reversal=240; 150)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
ECT (# patients evaluable for reversal=271; 182)
100.0
(100.0 to 100.0)
100.0
(100.0 to 100.0)
Time Frame From the first vial of idarucizumab until end of study (90 ± 7 days after the second vial).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Idarucizumab (Group A) Idarucizumab (Group B)
Hide Arm/Group Description Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes. Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
All-Cause Mortality
Idarucizumab (Group A) Idarucizumab (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idarucizumab (Group A) Idarucizumab (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   160/301 (53.16%)   106/202 (52.48%) 
Blood and lymphatic system disorders     
Anaemia  1  1/301 (0.33%)  1/202 (0.50%) 
Disseminated intravascular coagulation  1  1/301 (0.33%)  1/202 (0.50%) 
Haemorrhagic anaemia  1  0/301 (0.00%)  1/202 (0.50%) 
Hypocoagulable state  1  0/301 (0.00%)  1/202 (0.50%) 
Normochromic normocytic anaemia  1  0/301 (0.00%)  1/202 (0.50%) 
Pancytopenia  1  0/301 (0.00%)  1/202 (0.50%) 
Cardiac disorders     
Acute myocardial infarction  1  1/301 (0.33%)  2/202 (0.99%) 
Angina unstable  1  1/301 (0.33%)  0/202 (0.00%) 
Atrial fibrillation  1  2/301 (0.66%)  1/202 (0.50%) 
Atrial flutter  1  0/301 (0.00%)  1/202 (0.50%) 
Atrial tachycardia  1  1/301 (0.33%)  0/202 (0.00%) 
Atrial thrombosis  1  1/301 (0.33%)  0/202 (0.00%) 
Bradycardia  1  1/301 (0.33%)  1/202 (0.50%) 
Cardiac amyloidosis  1  1/301 (0.33%)  0/202 (0.00%) 
Cardiac arrest  1  1/301 (0.33%)  9/202 (4.46%) 
Cardiac failure  1  11/301 (3.65%)  4/202 (1.98%) 
Cardiac failure acute  1  0/301 (0.00%)  1/202 (0.50%) 
Cardiac failure chronic  1  3/301 (1.00%)  0/202 (0.00%) 
Cardiac failure congestive  1  10/301 (3.32%)  2/202 (0.99%) 
Cardiac tamponade  1  0/301 (0.00%)  1/202 (0.50%) 
Cardio-respiratory arrest  1  1/301 (0.33%)  1/202 (0.50%) 
Cardiogenic shock  1  1/301 (0.33%)  2/202 (0.99%) 
Coronary artery disease  1  0/301 (0.00%)  2/202 (0.99%) 
Mitral valve incompetence  1  0/301 (0.00%)  1/202 (0.50%) 
Myocardial infarction  1  3/301 (1.00%)  1/202 (0.50%) 
Myocardial ischaemia  1  1/301 (0.33%)  0/202 (0.00%) 
Pericardial effusion  1  0/301 (0.00%)  2/202 (0.99%) 
Pulseless electrical activity  1  1/301 (0.33%)  0/202 (0.00%) 
Right ventricular failure  1  0/301 (0.00%)  1/202 (0.50%) 
Ventricular fibrillation  1  1/301 (0.33%)  1/202 (0.50%) 
Ventricular tachycardia  1  1/301 (0.33%)  0/202 (0.00%) 
Endocrine disorders     
Thyroid haemorrhage  1  0/301 (0.00%)  1/202 (0.50%) 
Eye disorders     
Amaurosis fugax  1  1/301 (0.33%)  0/202 (0.00%) 
Vitreous floaters  1  1/301 (0.33%)  0/202 (0.00%) 
Gastrointestinal disorders     
Abdominal wall haematoma  1  0/301 (0.00%)  1/202 (0.50%) 
Anal haemorrhage  1  2/301 (0.66%)  0/202 (0.00%) 
Erosive duodenitis  1  0/301 (0.00%)  1/202 (0.50%) 
Gastric haemorrhage  1  0/301 (0.00%)  2/202 (0.99%) 
Gastric ulcer  1  0/301 (0.00%)  1/202 (0.50%) 
Gastrointestinal haemorrhage  1  4/301 (1.33%)  2/202 (0.99%) 
Gastrointestinal mucosal necrosis  1  1/301 (0.33%)  0/202 (0.00%) 
Gastrointestinal necrosis  1  1/301 (0.33%)  2/202 (0.99%) 
Gastrointestinal perforation  1  0/301 (0.00%)  1/202 (0.50%) 
Ileal ulcer  1  1/301 (0.33%)  0/202 (0.00%) 
Ileus paralytic  1  1/301 (0.33%)  0/202 (0.00%) 
Intestinal haemorrhage  1  0/301 (0.00%)  1/202 (0.50%) 
Intestinal ischaemia  1  1/301 (0.33%)  2/202 (0.99%) 
Intestinal obstruction  1  0/301 (0.00%)  1/202 (0.50%) 
Intestinal perforation  1  0/301 (0.00%)  2/202 (0.99%) 
Lower gastrointestinal haemorrhage  1  1/301 (0.33%)  1/202 (0.50%) 
Mallory-Weiss syndrome  1  1/301 (0.33%)  0/202 (0.00%) 
Melaena  1  2/301 (0.66%)  1/202 (0.50%) 
Pancreatitis  1  1/301 (0.33%)  1/202 (0.50%) 
Pancreatitis necrotising  1  0/301 (0.00%)  1/202 (0.50%) 
Proctitis  1  0/301 (0.00%)  1/202 (0.50%) 
Rectal haemorrhage  1  2/301 (0.66%)  1/202 (0.50%) 
Small intestinal obstruction  1  1/301 (0.33%)  0/202 (0.00%) 
Vomiting  1  1/301 (0.33%)  0/202 (0.00%) 
General disorders     
Adhesion  1  0/301 (0.00%)  1/202 (0.50%) 
Asthenia  1  1/301 (0.33%)  0/202 (0.00%) 
Chest pain  1  0/301 (0.00%)  1/202 (0.50%) 
General physical health deterioration  1  2/301 (0.66%)  2/202 (0.99%) 
Multiple organ dysfunction syndrome  1  2/301 (0.66%)  4/202 (1.98%) 
Oedema peripheral  1  0/301 (0.00%)  1/202 (0.50%) 
Pyrexia  1  1/301 (0.33%)  0/202 (0.00%) 
Sudden cardiac death  1  1/301 (0.33%)  0/202 (0.00%) 
Sudden death  1  2/301 (0.66%)  0/202 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/301 (0.00%)  1/202 (0.50%) 
Cholestasis  1  1/301 (0.33%)  0/202 (0.00%) 
Hepatic cirrhosis  1  1/301 (0.33%)  0/202 (0.00%) 
Hepatic function abnormal  1  1/301 (0.33%)  0/202 (0.00%) 
Ischaemic hepatitis  1  0/301 (0.00%)  1/202 (0.50%) 
Immune system disorders     
Anaphylactic reaction  1  0/301 (0.00%)  1/202 (0.50%) 
Anaphylactic shock  1  1/301 (0.33%)  0/202 (0.00%) 
Infections and infestations     
Abdominal sepsis  1  0/301 (0.00%)  1/202 (0.50%) 
Abscess limb  1  0/301 (0.00%)  1/202 (0.50%) 
Bronchitis  1  1/301 (0.33%)  0/202 (0.00%) 
Campylobacter gastroenteritis  1  1/301 (0.33%)  0/202 (0.00%) 
Cellulitis  1  1/301 (0.33%)  1/202 (0.50%) 
Clostridium difficile colitis  1  1/301 (0.33%)  0/202 (0.00%) 
Enterococcal sepsis  1  0/301 (0.00%)  1/202 (0.50%) 
Erysipelas  1  1/301 (0.33%)  0/202 (0.00%) 
Escherichia bacteraemia  1  1/301 (0.33%)  0/202 (0.00%) 
Escherichia sepsis  1  1/301 (0.33%)  0/202 (0.00%) 
Escherichia urinary tract infection  1  1/301 (0.33%)  0/202 (0.00%) 
H1N1 influenza  1  1/301 (0.33%)  0/202 (0.00%) 
Infection  1  1/301 (0.33%)  0/202 (0.00%) 
Infectious pleural effusion  1  0/301 (0.00%)  1/202 (0.50%) 
Influenza  1  0/301 (0.00%)  1/202 (0.50%) 
Liver abscess  1  0/301 (0.00%)  1/202 (0.50%) 
Mediastinitis  1  1/301 (0.33%)  0/202 (0.00%) 
Medical device site joint infection  1  0/301 (0.00%)  1/202 (0.50%) 
Oesophageal candidiasis  1  0/301 (0.00%)  1/202 (0.50%) 
Osteomyelitis  1  0/301 (0.00%)  1/202 (0.50%) 
Peritonitis  1  0/301 (0.00%)  2/202 (0.99%) 
Pneumonia  1  14/301 (4.65%)  7/202 (3.47%) 
Pneumonia bacterial  1  1/301 (0.33%)  0/202 (0.00%) 
Postoperative wound infection  1  0/301 (0.00%)  2/202 (0.99%) 
Pyelonephritis  1  1/301 (0.33%)  0/202 (0.00%) 
Respiratory tract infection  1  1/301 (0.33%)  1/202 (0.50%) 
Sepsis  1  7/301 (2.33%)  5/202 (2.48%) 
Septic shock  1  2/301 (0.66%)  11/202 (5.45%) 
Urinary tract infection  1  6/301 (1.99%)  0/202 (0.00%) 
Urosepsis  1  1/301 (0.33%)  1/202 (0.50%) 
Injury, poisoning and procedural complications     
Brain contusion  1  1/301 (0.33%)  0/202 (0.00%) 
Cystitis radiation  1  0/301 (0.00%)  1/202 (0.50%) 
Fall  1  1/301 (0.33%)  1/202 (0.50%) 
Femoral neck fracture  1  1/301 (0.33%)  0/202 (0.00%) 
Femur fracture  1  0/301 (0.00%)  1/202 (0.50%) 
Graft thrombosis  1  0/301 (0.00%)  1/202 (0.50%) 
Head injury  1  1/301 (0.33%)  0/202 (0.00%) 
Joint dislocation  1  1/301 (0.33%)  1/202 (0.50%) 
Periprosthetic fracture  1  0/301 (0.00%)  1/202 (0.50%) 
Post procedural complication  1  0/301 (0.00%)  1/202 (0.50%) 
Postoperative ileus  1  0/301 (0.00%)  1/202 (0.50%) 
Procedural haemorrhage  1  0/301 (0.00%)  1/202 (0.50%) 
Spinal compression fracture  1  0/301 (0.00%)  1/202 (0.50%) 
Stoma site irritation  1  1/301 (0.33%)  0/202 (0.00%) 
Subdural haematoma  1  9/301 (2.99%)  0/202 (0.00%) 
Subdural haemorrhage  1  1/301 (0.33%)  1/202 (0.50%) 
Traumatic haematoma  1  1/301 (0.33%)  0/202 (0.00%) 
Traumatic haemothorax  1  0/301 (0.00%)  1/202 (0.50%) 
Vascular pseudoaneurysm  1  0/301 (0.00%)  1/202 (0.50%) 
Wound haemorrhage  1  0/301 (0.00%)  1/202 (0.50%) 
Investigations     
Alanine aminotransferase increased  1  2/301 (0.66%)  0/202 (0.00%) 
Aspartate aminotransferase increased  1  1/301 (0.33%)  0/202 (0.00%) 
Blood bilirubin increased  1  2/301 (0.66%)  0/202 (0.00%) 
Haemoglobin decreased  1  0/301 (0.00%)  1/202 (0.50%) 
Metabolism and nutrition disorders     
Electrolyte imbalance  1  1/301 (0.33%)  0/202 (0.00%) 
Gout  1  0/301 (0.00%)  1/202 (0.50%) 
Hyperkalaemia  1  2/301 (0.66%)  1/202 (0.50%) 
Hyponatraemia  1  0/301 (0.00%)  1/202 (0.50%) 
Starvation  1  1/301 (0.33%)  0/202 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/301 (0.00%)  1/202 (0.50%) 
Rhabdomyolysis  1  0/301 (0.00%)  1/202 (0.50%) 
Tenosynovitis  1  1/301 (0.33%)  0/202 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  3/301 (1.00%)  1/202 (0.50%) 
Basal cell carcinoma  1  0/301 (0.00%)  1/202 (0.50%) 
Bile duct cancer  1  1/301 (0.33%)  0/202 (0.00%) 
Bronchial carcinoma  1  0/301 (0.00%)  1/202 (0.50%) 
Cervix carcinoma  1  1/301 (0.33%)  0/202 (0.00%) 
Colon cancer  1  2/301 (0.66%)  0/202 (0.00%) 
Colon neoplasm  1  1/301 (0.33%)  0/202 (0.00%) 
Diffuse large B-cell lymphoma  1  1/301 (0.33%)  0/202 (0.00%) 
Genital neoplasm malignant female  1  0/301 (0.00%)  1/202 (0.50%) 
Intestinal adenocarcinoma  1  1/301 (0.33%)  0/202 (0.00%) 
Malignant neoplasm progression  1  2/301 (0.66%)  1/202 (0.50%) 
Malignant pleural effusion  1  0/301 (0.00%)  1/202 (0.50%) 
Meningioma  1  1/301 (0.33%)  0/202 (0.00%) 
Neoplasm progression  1  1/301 (0.33%)  0/202 (0.00%) 
Pancreatic carcinoma  1  0/301 (0.00%)  1/202 (0.50%) 
Plasma cell myeloma  1  0/301 (0.00%)  1/202 (0.50%) 
Prostate cancer metastatic  1  1/301 (0.33%)  0/202 (0.00%) 
Rectal adenocarcinoma  1  1/301 (0.33%)  0/202 (0.00%) 
Nervous system disorders     
Basal ganglia haemorrhage  1  1/301 (0.33%)  0/202 (0.00%) 
Brain injury  1  1/301 (0.33%)  0/202 (0.00%) 
Brain oedema  1  1/301 (0.33%)  0/202 (0.00%) 
Brain stem haemorrhage  1  1/301 (0.33%)  0/202 (0.00%) 
Brain stem syndrome  1  1/301 (0.33%)  0/202 (0.00%) 
Cerebellar syndrome  1  1/301 (0.33%)  0/202 (0.00%) 
Cerebral haemorrhage  1  2/301 (0.66%)  0/202 (0.00%) 
Cerebral infarction  1  2/301 (0.66%)  1/202 (0.50%) 
Cerebrovascular accident  1  1/301 (0.33%)  0/202 (0.00%) 
Chorea  1  0/301 (0.00%)  1/202 (0.50%) 
Dementia  1  1/301 (0.33%)  1/202 (0.50%) 
Depressed level of consciousness  1  1/301 (0.33%)  0/202 (0.00%) 
Embolic cerebral infarction  1  1/301 (0.33%)  0/202 (0.00%) 
Encephalopathy  1  1/301 (0.33%)  0/202 (0.00%) 
Epilepsy  1  0/301 (0.00%)  1/202 (0.50%) 
Haemorrhage intracranial  1  5/301 (1.66%)  1/202 (0.50%) 
Headache  1  0/301 (0.00%)  1/202 (0.50%) 
Intracranial mass  1  1/301 (0.33%)  0/202 (0.00%) 
Ischaemic stroke  1  5/301 (1.66%)  2/202 (0.99%) 
Monoplegia  1  1/301 (0.33%)  0/202 (0.00%) 
Paraplegia  1  0/301 (0.00%)  1/202 (0.50%) 
Parkinson's disease  1  1/301 (0.33%)  0/202 (0.00%) 
Seizure  1  2/301 (0.66%)  1/202 (0.50%) 
Simple partial seizures  1  1/301 (0.33%)  0/202 (0.00%) 
Syncope  1  1/301 (0.33%)  0/202 (0.00%) 
Product Issues     
Device loosening  1  0/301 (0.00%)  1/202 (0.50%) 
Psychiatric disorders     
Delirium  1  13/301 (4.32%)  8/202 (3.96%) 
Hallucinations, mixed  1  1/301 (0.33%)  0/202 (0.00%) 
Mental status changes  1  2/301 (0.66%)  1/202 (0.50%) 
Renal and urinary disorders     
Acute kidney injury  1  5/301 (1.66%)  6/202 (2.97%) 
Anuria  1  3/301 (1.00%)  0/202 (0.00%) 
Chronic kidney disease  1  0/301 (0.00%)  1/202 (0.50%) 
Hydronephrosis  1  0/301 (0.00%)  3/202 (1.49%) 
Renal failure  1  1/301 (0.33%)  5/202 (2.48%) 
Renal haemorrhage  1  0/301 (0.00%)  1/202 (0.50%) 
Urinary retention  1  1/301 (0.33%)  0/202 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/301 (0.33%)  0/202 (0.00%) 
Acute respiratory failure  1  1/301 (0.33%)  1/202 (0.50%) 
Apnoea  1  1/301 (0.33%)  1/202 (0.50%) 
Chronic obstructive pulmonary disease  1  1/301 (0.33%)  1/202 (0.50%) 
Cough  1  1/301 (0.33%)  0/202 (0.00%) 
Dysphonia  1  1/301 (0.33%)  0/202 (0.00%) 
Hypoxia  1  1/301 (0.33%)  1/202 (0.50%) 
Pleural effusion  1  4/301 (1.33%)  3/202 (1.49%) 
Pneumonia aspiration  1  2/301 (0.66%)  0/202 (0.00%) 
Pneumonitis  1  1/301 (0.33%)  0/202 (0.00%) 
Pneumothorax  1  0/301 (0.00%)  2/202 (0.99%) 
Pulmonary embolism  1  5/301 (1.66%)  4/202 (1.98%) 
Pulmonary fibrosis  1  0/301 (0.00%)  1/202 (0.50%) 
Pulmonary haemorrhage  1  1/301 (0.33%)  0/202 (0.00%) 
Pulmonary hypertension  1  2/301 (0.66%)  0/202 (0.00%) 
Pulmonary oedema  1  7/301 (2.33%)  3/202 (1.49%) 
Respiratory arrest  1  1/301 (0.33%)  0/202 (0.00%) 
Respiratory failure  1  7/301 (2.33%)  4/202 (1.98%) 
Skin and subcutaneous tissue disorders     
Skin necrosis  1  0/301 (0.00%)  2/202 (0.99%) 
Subcutaneous emphysema  1  0/301 (0.00%)  1/202 (0.50%) 
Vascular disorders     
Aortic aneurysm rupture  1  1/301 (0.33%)  0/202 (0.00%) 
Circulatory collapse  1  0/301 (0.00%)  1/202 (0.50%) 
Deep vein thrombosis  1  7/301 (2.33%)  3/202 (1.49%) 
Haematoma  1  0/301 (0.00%)  1/202 (0.50%) 
Hypertensive crisis  1  1/301 (0.33%)  0/202 (0.00%) 
Hypotension  1  1/301 (0.33%)  1/202 (0.50%) 
Peripheral arterial occlusive disease  1  1/301 (0.33%)  0/202 (0.00%) 
Peripheral embolism  1  0/301 (0.00%)  1/202 (0.50%) 
Peripheral ischaemia  1  1/301 (0.33%)  2/202 (0.99%) 
Shock  1  0/301 (0.00%)  2/202 (0.99%) 
Shock haemorrhagic  1  1/301 (0.33%)  1/202 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idarucizumab (Group A) Idarucizumab (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   139/301 (46.18%)   86/202 (42.57%) 
Blood and lymphatic system disorders     
Anaemia  1  13/301 (4.32%)  11/202 (5.45%) 
Gastrointestinal disorders     
Constipation  1  33/301 (10.96%)  20/202 (9.90%) 
Diarrhoea  1  14/301 (4.65%)  18/202 (8.91%) 
Nausea  1  21/301 (6.98%)  18/202 (8.91%) 
General disorders     
Oedema peripheral  1  17/301 (5.65%)  14/202 (6.93%) 
Pyrexia  1  23/301 (7.64%)  6/202 (2.97%) 
Infections and infestations     
Urinary tract infection  1  35/301 (11.63%)  17/202 (8.42%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  23/301 (7.64%)  8/202 (3.96%) 
Nervous system disorders     
Dizziness  1  9/301 (2.99%)  11/202 (5.45%) 
Headache  1  27/301 (8.97%)  6/202 (2.97%) 
Psychiatric disorders     
Confusional state  1  8/301 (2.66%)  13/202 (6.44%) 
Renal and urinary disorders     
Haematuria  1  18/301 (5.98%)  6/202 (2.97%) 
Vascular disorders     
Hypotension  1  17/301 (5.65%)  15/202 (7.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02104947     History of Changes
Other Study ID Numbers: 1321.3
2013-004813-41 ( EudraCT Number )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: July 21, 2017
Results First Posted: August 18, 2017
Last Update Posted: January 5, 2018