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

Coronary Artery Disease Clinical Trial

— EASTS  

Official title:

Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01233167
• Other study ID #: SRRSH-CVD-001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 1, 2010
• Last updated: July 19, 2011
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2010
• Source: Sir Run Run Shaw Hospital
• Contact: He Huang, Doctor of Medicine
• Phone: 860571-86006246
• Email: huanghell[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5232
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• clopidogrel
clopidogrel 75 mg po per day for 12 months
• placebo
placebo 75mg po per day for 12 months
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	Yes
Primary	nonfatal myocardial infarction		one year	No
Primary	clinical-driven target vessel revascularization		one year	No
Primary	cardiac death		one year	Yes
Primary	stent thrombosis		one year	Yes
Secondary	death		one year	Yes
Secondary	myocardial infarction		one year	No
Secondary	any repeat revascularization		one year	No
Secondary	strokes		one year	No
Secondary	dialysis/hemofiltration		one year	No
Secondary	bleeding events		one year	Yes