Coronary Artery Disease
Conditions
Keywords
dual antiplatelet therapy, sirolimus drug-eluting stent, major adverse cardiac events, bleeding
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.
Interventions
DRUGclopidogrel
clopidogrel 75 mg po per day for 12 months
DRUGplacebo
placebo 75mg po per day for 12 months
DRUGclopidogrel and placebo
clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| death | one year |
| bleeding events | one year |
| myocardial infarction | one year |
| any repeat revascularization | one year |
| strokes | one year |
| dialysis/hemofiltration | one year |
Contacts
Primary ContactHe Huang, Doctor of Medicine
Backup ContactGuo-sheng Fu, Doctor of Philosopy
Outcome results
None listed