Antiplatelet
Conditions
Brief summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Interventions
DRUGPrasugrel 10mg
Prasugrel 10mg dispensing claim is used as the exposure group
DRUGClopidogrel 75mg
Clopidogrel 75 mg dispensing claim is used as the reference group
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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: 1. ST-segment elevation 1 mm or higher in 2 or more contiguous ECG leads 2. New or presumably new left bundle branch block 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative hazard of 3-P MACE (composite outcome of Stroke, MI, and Mortality) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative hazard of Hospital admission for MI | 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. |
| Relative hazard of Hospital admission for stroke | 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. |
| Relative hazard of All-cause mortality/CV mortality | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relative hazard of Major bleeding (Control outcome) | 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. |
| Relative hazard of Pneumonia (Control outcome) | 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. |
Countries
United States
Outcome results
None listed