Antiplatelet Clinical Trial
Official title:
Replication of the PLATO Antiplatelet Trial in Healthcare Claims Data
Verified date | July 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 27960 |
Est. completion date | February 18, 2021 |
Est. primary completion date | February 18, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Market availability of ticagrelor in the U.S. started on 2011-07-20. - For Marketscan: 2011-07-20 to 2017-12-31 (end of data availability). - For Optum: 2011-07-20 to 2019-03-31 (end of data availability). Inclusion Criteria: - 1-4 ALL REQUIRED - 1. Hospitalized for potential ST-segment elevation or non-ST-segment elevation ACS, with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of =10 minutes' duration at rest - 2. =18 years of age - 3. Not pregnant. Urinary and/or blood pregnancy tests are to be performed in women of child-bearing potential and repeated at least every 6 months. Women of child-bearing potential must be using =2 forms of reliable contraception, including one barrier method. - 4. With informed consent 1-4 AND 5A OR 5B - 5A. =2 of the following: - 1. ST-segment changes on ECG indicating ischemia. ST-segment depression or transient elevation = 1 mm in two or more 2 contiguous leads" - 2. Positive biomarker indicating myocardial necrosis. Troponin I or T or CK-MB greater than the upper limit of normal - 3. One of the following: 1. =60 y of age 2. Previous MI or CABG 3. CAD with =50% stenosis in =2 vessels 4. Previous ischemic stroke, TIA (hospital-based diagnosis), carotid stenosis (=50%), or cerebral revascularization 5. Diabetes mellitus 6. Peripheral artery disease 7. Chronic renal dysfunction - OR - 5B. Persistent ST-segment elevation =1 mm (not known to be preexisting or due to a coexisting disorder) in =2 contiguous leads or new LBBB plus primary PCI planned. Exclusion Criteria: - Drug related - 1. Contraindication to clopidogrel or other reason that study drug should not be administered (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, major surgery within 30 days)" - 2. Oral anticoagulation therapy that cannot be stopped - 3. Fibrinolytic therapy planned or within the previous 24 h - 4. Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine) - Treatment related - 1. Index event is an acute complication of PCI - 2. PCI after index event and before first study dose - Medical - 1. Increased risk of bradycardiac events - 2. Dialysis required - 3. Known clinically important thrombocytopenia - 4. Known clinically important anemia - 5. Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer) - General - 1. Participant in another investigational drug or device study within 30 days - 2. Pregnancy or lactation - 3. Any condition that increases the risk for noncompliance or being lost to follow-up - 4. Involvement in the planning or conduct of the study - 5. Previous enrollment or randomization in this study |
Country | Name | City | State |
---|---|---|---|
United States | Brigham And Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relative hazard of Major bleeding (Control outcome) | 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 163-219 days) | |
Other | Relative hazard of Pneumonia (Control outcome) | Relative hazard of Pneumonia (Control outcome) - Please refer to uploaded protocol for full definition due to size limitations. | Through study completion (a median of 163-219 days) | |
Primary | Relative hazard of 3-P MACE (composite outcome of Stroke, MI, and Mortality) | 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 163-219 days) | |
Secondary | Relative hazard of Hospital admission for MI | 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 163-219 days) | |
Secondary | Relative hazard of Hospital admission for stroke | 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 163-219 days) | |
Secondary | Relative hazard of All-cause mortality/CV mortality | 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 163-219 days) |
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