Fixed-dose vs. Phenotype-based PrAsugrel Dose to MATCH Therapeutic Zone in Asians With Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the fixed-dose (prasugrel 10 mg/d vs. 5 mg/d) vs. phenotype (platlet function test by VerifyNow P2Y12 assay)-based prasugrel dose adjustment can match therapeutic zone of platelet reactivity in PCI-treated Asians with acute coronary syndrome

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gyeongsang National University Hospital
• Treatments: Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Acute coronary syndrome (unstable angina, NSTEMI, and STEMI)

• Significant coronary artery stenosis (>50% by visual estimate) eligible for coronary stenting

• Between 20 and 75 years of age

• Body weight ≥ 60kg

• Aspirin dose of 100 mg is recommended

• Ability to understand and to comply with the study protocol

Exclusion Criteria:

• Prior history of ischemic or hemorrhagic stroke or transient ischemic attack, or sub-arachnoids hemorrhage

• fibrinolytic or abciximab therapy within 48 hours of entry or randomization into the study

• vitamin K antagonist

• History of intolerance or allergy to ASA or approved thienopyridines (ticlopidine, clopidogrel, or prasugrel)

• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

• active pathological bleeding or history of bleeding diathesis

• Thrombocytopenia (platelets < 100,000/mm3)

• Severe hepatic impairment (Child Pugh class C).

• a condition associated with poor treatment compliance, including dementia or mental illness