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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:
Information provided by (Responsible Party):

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

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

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

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information

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