Acute Coronary Syndromes, Clopidogrel Low Responsiveness, Percutaneous Coronary Intervention
Conditions
Keywords
antiplatelet therapy, clopidogrel low responsiveness, acute coronary syndromes, percutaneous coronary intervention, cilostazol
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.
Interventions
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.
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
l: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major ischemic cardiovascular events | 1 year | defined as a composite of cardiac death, myocardial infarction or stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed