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

NCT ID: NCT01094457

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Acute Coronary Syndromes; Percutaneous Coronary Intervention; Clopidogrel Low Responsiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard group

patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d

Group Type: ACTIVE_COMPARATOR

aspirin, clopidogrel

Intervention Type: DRUG

patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year

intensive group

patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA

Group Type: EXPERIMENTAL

aspirin, clopidogrel, cilostazol

Intervention Type: DRUG

Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.

Interventions

aspirin, clopidogrel

patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year

Intervention Type: DRUG

aspirin, clopidogrel, cilostazol

Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• aged 35 to 75 years
• acute coronary syndromes
• underwent successful coronary stent implantation
• informed consent

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yaling Han

vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaling Han, MD

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

463 Hospital of PLA

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shenyang Northern Hospital

Shenyang, Liaoning, China

Countries

China

Other Identifiers

825004-5

Identifier Type: -

Identifier Source: org_study_id