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| ID | Type | Description | Link |
|---|---|---|---|
| FWA # 00005656 and 00005651 |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
| Accumetrics, Inc. | INDUSTRY |
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The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.
Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SA + 5mg prasugrel | Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin. | ||
| ASA + 10 mg prasugrel | Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin. | ||
| ASA + 75 mg clopidogrel daily | Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age >75; Wt< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin. |
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| Measure | Description | Time Frame |
|---|---|---|
| MACE | Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of major bleeding | The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects in any of the participating sites who are on chronic clopidogrel treatment and return for PCI will be considered for this study.
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| Name | Affiliation | Role |
|---|---|---|
| George Dangas, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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