Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation

Phase 4

Completed

• Conditions: Acute Coronary Syndromes; Percutaneous Coronary Intervention; Clopidogrel Low Responsiveness
• Interventions: Drug: aspirin, clopidogrel; Drug: aspirin, clopidogrel, cilostazol

• Registration Number: NCT01094457
• Lead Sponsor: Shenyang Northern Hospital

Brief Summary

Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Primary Completion: 2012-04
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

Not provided

Exclusion Criteria

• contraindications to antiplatelet therapy
• history of intracranial bleeding
• known bleeding disorders
• severe liver or kidney disease
• pregnancy
• left main coronary artery disease
• planned non cardiac surgery within 1 year
• end stage of other serious disease with life expectancy less than 1 year
• heart failure with NYHA grade 3 to 4

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard group	aspirin, clopidogrel	patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d
intensive group	aspirin, clopidogrel, cilostazol	patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA

Primary Outcome Measures

Name	Time	Method
Major ischemic cardiovascular events	1 year	defined as a composite of cardiac death, myocardial infarction or stroke

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis	1 year	according to ARC definition
major adverse cardiac and cerebral events(MACCE)	1 year	defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke
Hemorrhagic events	within 1 year	according to TIMI bleeding definition
reduction in ADP induced platelet aggregation	30 days	assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)

Trial Locations

Locations (3)

Shenyang Northern Hospital; 🇨🇳 Shenyang, Liaoning, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

463 Hospital of PLA; 🇨🇳 Shenyang, Liaoning, China