Clinical trial NCT01233167: Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
Official title: Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: dual antiplatelet therapy
sirolimus drug-eluting stent
major adverse cardiac events
bleeding
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 5232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: all cause mortality
timeFrame: one year
measure: nonfatal myocardial infarction
timeFrame: one year
measure: clinical-driven target vessel revascularization
timeFrame: one year
measure: cardiac death
timeFrame: one year
measure: stent thrombosis
timeFrame: one year
Secondary outcomes:
measure: death
timeFrame: one year
measure: myocardial infarction
timeFrame: one year
measure: any repeat revascularization
timeFrame: one year
measure: strokes
timeFrame: one year
measure: dialysis/hemofiltration
timeFrame: one year
measure: bleeding events
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References: