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

Zhejiang University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Drug: clopidogrel; Drug: placebo; Drug: clopidogrel and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01233167

SRRSH-CVD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,232 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5,232 participants in 3 patient groups, including a placebo group

clopidogrel

Experimental group

Treatment:

Drug: clopidogrel

placebo

Placebo Comparator group

Treatment:

Drug: placebo

steply discontinued clopidogrel

Experimental group

Treatment:

Drug: clopidogrel and placebo