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Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery (INTREPID)

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ClinicalTrials.gov Identifier: NCT02291419
Recruitment Status : Terminated (Enrollment expectations were not met)
First Posted : November 14, 2014
Results First Posted : February 9, 2017
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Venu Menon, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Myocardial Injury
Interventions Drug: ticagrelor
Drug: aspirin
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Period Title: Overall Study
Started 1 5
Completed 0 0
Not Completed 1 5
Reason Not Completed
Early study termination             1             5
Arm/Group Title Ticagrelor Aspirin Total
Hide Arm/Group Description

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Total of all reporting groups
Overall Number of Baseline Participants 1 5 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
> or = to 40 years Number Analyzed 1 participants 5 participants 6 participants
1
 100.0%
5
 100.0%
6
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 5 participants 6 participants
Female
0
   0.0%
3
  60.0%
3
  50.0%
Male
1
 100.0%
2
  40.0%
3
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants 5 participants 6 participants
1
 100.0%
5
 100.0%
6
 100.0%
1.Primary Outcome
Title Major Adverse Cardiovascular Events
Hide Description Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.
Time Frame up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Overall Number of Participants Analyzed 1 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Cardiovascular Death
Hide Description Time to first occurence of Cardiovascular death. The number of patients with events was reported.
Time Frame Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Overall Number of Participants Analyzed 1 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Non-fatal Myocardial Infarction or Coronary Revascularization
Hide Description Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.
Time Frame up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Overall Number of Participants Analyzed 1 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title All-cause Death
Hide Description Time to first occurence of All-cause death. The number of participants with events was reported.
Time Frame up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Overall Number of Participants Analyzed 1 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Non-fatal Stroke
Hide Description Time to first occurence of Non-fatal stroke. The number of participants with events was reported.
Time Frame up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Overall Number of Participants Analyzed 1 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Other Pre-specified Outcome
Title The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions
Hide Description [Not Specified]
Time Frame up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

Overall Number of Participants Analyzed 1 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Patients were monitored up to 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily

All-Cause Mortality
Ticagrelor Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ticagrelor Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Venu Menon
Organization: Cleveland Clinic
Phone: 216-445-5390
Publications:
Responsible Party: Venu Menon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02291419     History of Changes
Other Study ID Numbers: CCAZ-2014
First Submitted: November 5, 2014
First Posted: November 14, 2014
Results First Submitted: February 8, 2017
Results First Posted: February 9, 2017
Last Update Posted: February 9, 2017