- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04237922
Replication of the TRITON-TIMI Antiplatelet Trial in Healthcare Claims Data
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Market availability of prasugrel in the U.S. started on 2009-07-10.
- For Marketscan: 2009-07-10 to 2017-12-31 (end of data availability).
- For Optum: 2009-07-10 to 2019-03-31 (end of data availability).
Inclusion Criteria:
1. Acute coronary syndrome based on the disease diagnostic criteria with planned PCI (ACS definition; one of the following):
- 1a. Moderate to high risk Unstable angina: A history of chest discomfort or ischemic symptoms of 10 min or longer at rest, 72 h or less before randomization, with persistent or transient ST-segment deviation 1 mm or higher in one or more electrocardiogram (ECG) leads without elevation of creatine kinase-MB (CK-MB) or troponin T or I but with a TIMI risk score 321 or greater
- 1b. II. Moderate to high-risk NSTEMI. A history of chest discomfort or ischemic symptoms of 10 min or longer at rest, 72 h or less before randomization with no evidence of persistent ST-segment elevation. Subjects must also have CK-MB or troponin T or I greater than the upper limit of normal (ULN) and a TIMI risk score 3 or greater. If CK-MB or troponin is not available, total CK 2 times or greater ULN is acceptable
1c. III. STEMI. A history of chest discomfort or ischemic symptoms of greater than 20 minutes duration at rest, within 14 days or less randomization with one of the following ECG features:
- ST-segment elevation 1 mm or higher in 2 or more contiguous ECG leads
- New or presumably new left bundle branch block
- ST-segment depression 1 mm or greater in 2 anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction"
- 2. Legal age (and >18 y) and competent mental condition to provide written informed consent
- 3. For women of childbearing potential only, test negative for pregnancy between ACS presentation and enrollment (based on a urine or serum pregnancy test) and agree to use a reliable method of birth control during the study
Exclusion Criteria:
Cardiovascular exclusion criteria
- 1. Cardiogenic shock at the time of randomization
- 2. Refractory ventricular arrhythmias
- 3. New York Heart Association class IV congestive heart failure
Bleeding risk exclusion criteria
- 4. Fibrin-specific fibrinolytic therapy less than 24 h before randomization
- 5. Non-fibrin-specific fibrinolytic therapy less than 48 h before randomization
- 6. Active internal bleeding or history of bleeding diathesis
- 7. Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
8. Any of the following:
- History of hemorrhagic stroke
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Ischemic stroke within 3 months prior to screening
- 9. International normalized ratio known to be greater than 1.5 at the time of screening
- 10. Platelet count of less than 100000/mm3 at the time of screening
- 11. Anemia (hemoglobin b10 g/dL) at the time of screening
Prior/concomitant therapy exclusion criteria
- 12. One or more doses of a thienopyridine 5 d or less before PCI
- 13. Oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study
- 14. Daily treatment with nonsteroidal antiinflammatory drugs (NSAIDs) or cyclooxygenase-2 inhibitors (COX-2 inhibitors)
General exclusion criteria
- 15. Investigative site personnel directly affiliated with the study or immediate family
- 16. Employed by Eli Lilly and Company; Ube Industries Limited, Daiichi Sankyo Co.; The TIMI Study Group; Quintiles
- 17. Treatment within the last 30 d with an investigational drug or are presently enrolled in another drug or device study
- 18. Previously completed or withdrawn from this study or any other study investigating prasugrel
- 19. Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding
- 20. Concomitant medical illness that in the opinion of the investigator is associated with reduced survival
- 21. Known severe hepatic dysfunction
- 22. Any condition associated with poor treatment compliance including alcoholism, mental illness, or drug dependence
- 23. Intolerance of or allergy to aspirin, tilopidine, or clopidogrel
- 24. May be unable to cooperate with protocol requirements and follow-up procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clopidogrel 75 mg
Reference group
|
Clopidogrel 75 mg dispensing claim is used as the reference group
|
Prasugrel 10 mg
Exposure group
|
Prasugrel 10mg dispensing claim is used as the exposure group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of 3-P MACE (composite outcome of Stroke, MI, and Mortality)
Time Frame: Through study completion (a median of 276-312 days)
|
Relative hazard of 3-point major adverse cardiovascular events (MACE), i.e., non-fatal myocardial infarction, non-fatal stroke, or all-cause/CV mortality- Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of 276-312 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of Hospital admission for MI
Time Frame: Through study completion (a median of 276-312 days)
|
Relative hazard of Hospital admission for MI - Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of 276-312 days)
|
Relative hazard of Hospital admission for stroke
Time Frame: Through study completion (a median of 276-312 days)
|
Relative hazard of Hospital admission for stroke - Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of 276-312 days)
|
Relative hazard of All-cause mortality/CV mortality
Time Frame: Through study completion (a median of 276-312 days)
|
Relative hazard of All-cause mortality/CV mortality- Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of 276-312 days)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of Major bleeding (Control outcome)
Time Frame: Through study completion (a median of 276-312 days)
|
Relative hazard of Major bleeding (Control outcome) - Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of 276-312 days)
|
Relative hazard of Pneumonia (Control outcome)
Time Frame: Through study completion (a median of 276-312 days)
|
Relative hazard of Pneumonia (Control outcome) - Please refer to uploaded protocol for full definition due to size limitations.
|
Through study completion (a median of 276-312 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P002966-DUP-TRITON-TIMI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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