Acute Coronary Syndromes Clinical Trial
— PRAISE-GENEOfficial title:
Phase 3 Study Comparing the Efficacy and Safety of Prasugrel and Clopidogrel in Acute Coronary Syndrome Patients With CYP2C19 Polymorphism Who Undergo Percutaneous Coronary Intervention.
Verified date | February 2019 |
Source | Dong-A University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 2019 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Acute coronary syndrome - Patients planned to undergo percutaneous transluminal coronary angioplasty - Patients who agreed to the experimental plan which was permitted by IRB Exclusion Criteria: - Low body weight (< 50kg) - History of stroke or transient ischemic attack - History of upper gastrointestinal bleeding in recent 6 months - Renal dysfunction defined by serum creatinine > 2.5 mg/dl - Severe hepatic dysfunction defined by Child-Pugh criteria B or C - Bleeding tendency - Anticoagulation treatment including warfarin - Thrombocytopenia defined by platelet < 100,000/ml - Anemia defined by hemoglobin < 10 g/dl - Contraindication for antiplatelet treatment or anticoagulation treatment - History of administer glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | DongA University Hospital | Busan |
Lead Sponsor | Collaborator |
---|---|
Dong-A University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HPR 1 day | High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI | 24 hours after PCI | |
Secondary | MACE | Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I) | 30 days | |
Secondary | Bleeding | Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria | 30 days | |
Secondary | HPRs | High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI | 4 hours after PCI, 30 days after PCI | |
Secondary | HPR by VASP at 24 hours | HPR defined by VASP at 24 hours after PCI | 24 hours from PCI | |
Secondary | HPR by VASP at 30 days | HPR by VASP at 30 days from PCI | 30 days from PCI |
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