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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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clopidogrel

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

clopidogrel 75 mg po per day for 12 months

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 75mg po per day for 12 months

steply discontinued clopidogrel

Group Type EXPERIMENTAL

clopidogrel and placebo

Intervention Type DRUG

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

Interventions

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clopidogrel

clopidogrel 75 mg po per day for 12 months

Intervention Type DRUG

placebo

placebo 75mg po per day for 12 months

Intervention Type 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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No