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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Drug: clopidogrel; Drug: placebo; Drug: clopidogrel and placebo

• Registration Number: NCT01233167
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20
• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clopidogrel	clopidogrel	-
placebo	placebo	-
steply discontinued clopidogrel	clopidogrel and placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
death	one year
myocardial infarction	one year
any repeat revascularization	one year
strokes	one year
dialysis/hemofiltration	one year
bleeding events	one year