Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

Shenyang Northern Hospital

Status and phase: Completed; Phase 4

Conditions: Ischemic Heart Disease; Acute Coronary Syndromes

Treatments: Drug: cilostazol in addition to aspirin and clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00404781

NH-2006-C001

Details and patient eligibility

About

Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.

Enrollment: 305 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non-ST-segment elevated acute coronary syndromes
• patients undergoing selective or emergent PCI

Exclusion criteria

• administration of clopidogrel or ticlopidine within 2 weeks
• ST-segment elevated myocardial infarction
• contraindications of antiplatelet therapy
• history of intracranial bleeding
• known bleeding disorders
• severe liver or kidney disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 2 patient groups

optimal antiplatelet

Experimental group

Description:

cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance

Treatment:

Drug: cilostazol in addition to aspirin and clopidogrel

standard antiplatelet

Active Comparator group

Description:

aspirin and clopidogrel for all patients

Treatment:

Drug: cilostazol in addition to aspirin and clopidogrel