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

Shenyang Northern Hospital

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndromes; Clopidogrel Low Responsiveness

Treatments: Drug: aspirin, clopidogrel, cilostazol; Drug: aspirin, clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01094457

825004-5

Details and patient eligibility

About

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.

Enrollment: 840 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criterial:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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840 participants in 2 patient groups

standard group

Active Comparator group

Description:

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

Treatment:

Drug: aspirin, clopidogrel

intensive group

Experimental group

Description:

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

Treatment:

Drug: aspirin, clopidogrel, cilostazol