Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation
Overview
- Phase
- Not Applicable
- Intervention
- clopidogrel
- Conditions
- Coronary Artery Disease
- Sponsor
- Sir Run Run Shaw Hospital
- Enrollment
- 5232
- Primary Endpoint
- all cause mortality
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
clopidogrel
Intervention: clopidogrel
placebo
Intervention: placebo
steply discontinued clopidogrel
Intervention: clopidogrel and placebo
Outcomes
Primary Outcomes
all cause mortality
Time Frame: one year
nonfatal myocardial infarction
Time Frame: one year
clinical-driven target vessel revascularization
Time Frame: one year
cardiac death
Time Frame: one year
stent thrombosis
Time Frame: one year
Secondary Outcomes
- death(one year)
- myocardial infarction(one year)
- any repeat revascularization(one year)
- strokes(one year)
- dialysis/hemofiltration(one year)
- bleeding events(one year)