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

Sponsor

Sir Run Run Shaw Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01233167

Collaborator

(none)

5,232

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: clopidogrel Drug: placebo Drug: clopidogrel and placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: clopidogrel	Drug: clopidogrel clopidogrel 75 mg po per day for 12 months
Placebo Comparator: placebo	Drug: placebo placebo 75mg po per day for 12 months
Experimental: steply discontinued clopidogrel	Drug: clopidogrel and placebo clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months

Arm

Intervention/Treatment

Experimental: clopidogrel

Drug: clopidogrel

clopidogrel 75 mg po per day for 12 months

Placebo Comparator: placebo

Drug: placebo

placebo 75mg po per day for 12 months

Experimental: steply discontinued clopidogrel

Drug: clopidogrel and placebo

clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months

Outcome Measures

Primary Outcome Measures

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

death [one year]
myocardial infarction [one year]
any repeat revascularization [one year]
strokes [one year]
dialysis/hemofiltration [one year]
bleeding events [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.