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

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Run Run Shaw Hospital
• Treatments: Clopidogrel; Everolimus; Sirolimus; Ticlopidine

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.