Status:
UNKNOWN
Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 1...
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 rat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
5232 Patients enrolled
Trial Details
Trial ID
NCT01233167
Start Date
August 1 2011
End Date
May 1 2013
Last Update
July 20 2011
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