Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

Phase 4

Completed

• Conditions: Ischemic Heart Disease; Acute Coronary Syndromes
• Interventions: Drug: cilostazol in addition to aspirin and clopidogrel

• Registration Number: NCT00404781
• Lead Sponsor: Shenyang Northern Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-29
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-13
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
optimal antiplatelet	cilostazol in addition to aspirin and clopidogrel	cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance
standard antiplatelet	cilostazol in addition to aspirin and clopidogrel	aspirin and clopidogrel for all patients

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebral events at 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
Hemorrhage events at 1 year	1 year

Trial Locations

Locations (1)

Northern Hospital; 🇨🇳 Shenyang, Liaoning, China