Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation

Study Overview
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Brief Summary
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The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.

Detailed Description
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It is not clear that dual antiplatelet therapy is better than aspirin beyond 12-months period patients receiving sirolimus drug-eluting stent implantation. If aspirin plus clopidogrel reduced MACE rates without increasing blood events, the investigators will evaluate risk-benefit ratio. The investigators will observe all cause mortality, nonfatal myocardial infarction, or clinical-driven target vessel revascularization TVR in a 1-year trial duration. In addition, strokes, stent thrombosis, cardiac re-hospitalizations, dialysis/hemofiltration, duration of hospitalization and bleeding events will be observed.

Official Title
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Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: clopidogrel
* Drug: placebo
* Drug: clopidogrel and placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of older. The latest PCI with DES implantation before 12 months (stents must be one or more sirolimus-eluting stents). Angiographically confirmed major epicardial vessels (>=2.5mm in diameter) without significant stenosis or restenosis (>=50%). Geographically accessible and willing to come in for required study visits. Signed informed consent. Exclusion Criteria: The patient has a known hypersensitivity or contraindication to aspirin and clopidogrel. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment and within 12 months. EF<35% within 12 months. Severe cardiac valves disease, or idiopathic cardiomyopathy such as dilated cardiomyopathy, hypotrophic cardiomyopathy. Other severe system diseases. Previous ACS within 12 months. Previous stroke or transient ischemia attack within 12 months. Previous myocardial infarction and clinical-driven target vessel revascularization within 12 months. Current enrollment in another clinical trial. Suspected pregnancy. Big bleeding events within 12 months. Planned surgical procedure. Previous other type DES implantation or BMS implantation history. Extra-cardiac stent implantation history. Current or planned dialysis. The patient has a known hypersensitivity or contraindication to statins. Current or planned high dose and long-term glucocorticoid treatment. that is expected to limit survival to less than 1 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clopidogrel<br> | Drug: clopidogrel<br>* clopidogrel 75 mg po per day for 12 months<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo 75mg po per day for 12 months<br>|
| Experimental: steply discontinued clopidogrel<br> | Drug: clopidogrel and placebo<br>* clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 
| nonfatal myocardial infarction |  | one year | 
| clinical-driven target vessel revascularization |  | one year | 
| cardiac death |  | one year | 
| stent thrombosis |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | one year | 
| myocardial infarction |  | one year | 
| any repeat revascularization |  | one year | 
| strokes |  | one year | 
| dialysis/hemofiltration |  | one year | 
| bleeding events |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual antiplatelet therapy, sirolimus drug-eluting stent, major adverse cardiac events, bleeding