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

This study has been terminated.
(Enrollment expectations were not met)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02291419
First Posted: November 14, 2014
Last Update Posted: February 9, 2017
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.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Venu Menon, The Cleveland Clinic
Results First Submitted: February 8, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Participant Flow:   Overall Study
    Ticagrelor   Aspirin
STARTED   1   5 
COMPLETED   0   0 
NOT COMPLETED   1   5 
Early study termination                1                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily

Total Total of all reporting groups

Baseline Measures
   Ticagrelor   Aspirin   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   5   6 
Age, Customized 
[Units: Participants]
Count of Participants
     
> or = to 40 years   1   5   6 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      3  60.0%      3  50.0% 
Male      1 100.0%      2  40.0%      3  50.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   1   5   6 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Major Adverse Cardiovascular Events   [ Time Frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months. ]

Measure Type Primary
Measure Title Major Adverse Cardiovascular Events
Measure 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.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Measured Values
   Ticagrelor   Aspirin 
Participants Analyzed 
[Units: Participants]
 1   5 
Major Adverse Cardiovascular Events 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for Major Adverse Cardiovascular Events



2.  Secondary:   Cardiovascular Death   [ Time Frame: Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months. ]

Measure Type Secondary
Measure Title Cardiovascular Death
Measure 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.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Measured Values
   Ticagrelor   Aspirin 
Participants Analyzed 
[Units: Participants]
 1   5 
Cardiovascular Death 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for Cardiovascular Death



3.  Secondary:   Non-fatal Myocardial Infarction or Coronary Revascularization   [ Time Frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months. ]

Measure Type Secondary
Measure Title Non-fatal Myocardial Infarction or Coronary Revascularization
Measure 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.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Measured Values
   Ticagrelor   Aspirin 
Participants Analyzed 
[Units: Participants]
 1   5 
Non-fatal Myocardial Infarction or Coronary Revascularization 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for Non-fatal Myocardial Infarction or Coronary Revascularization



4.  Secondary:   All-cause Death   [ Time Frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months. ]

Measure Type Secondary
Measure Title All-cause Death
Measure 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.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Measured Values
   Ticagrelor   Aspirin 
Participants Analyzed 
[Units: Participants]
 1   5 
All-cause Death 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for All-cause Death



5.  Secondary:   Non-fatal Stroke   [ Time Frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months. ]

Measure Type Secondary
Measure Title Non-fatal Stroke
Measure 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.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Measured Values
   Ticagrelor   Aspirin 
Participants Analyzed 
[Units: Participants]
 1   5 
Non-fatal Stroke 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for Non-fatal Stroke



6.  Other Pre-specified:   The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions   [ Time Frame: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months. ]

Measure Type Other Pre-specified
Measure Title The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions
Measure Description No text entered.
Time Frame up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ticagrelor

ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid

Aspirin

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

aspirin: aspirin 81 mg daily


Measured Values
   Ticagrelor   Aspirin 
Participants Analyzed 
[Units: Participants]
 1   5 
The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions 
[Units: Participants]
Count of Participants
 0   0 

No statistical analysis provided for The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: menonv@ccf.org


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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