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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
840
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
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.
463 Hospital of PLA
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shenyang Northern Hospital
Shenyang, Liaoning, China
Major ischemic cardiovascular events
defined as a composite of cardiac death, myocardial infarction or stroke
Time frame: 1 year
Stent thrombosis
according to ARC definition
Time frame: 1 year
major adverse cardiac and cerebral events(MACCE)
defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke
Time frame: 1 year
Hemorrhagic events
according to TIMI bleeding definition
Time frame: within 1 year
reduction in ADP induced platelet aggregation
assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)
Time frame: 30 days
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