NCT01094457

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: Shenyang Northern Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2010-03-29
• Last updated: 2012-06-14

Locations

3 sites across 1 country: China