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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: clopidogrel; Drug: placebo; Drug: clopidogrel and placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: He Huang, Doctor of Medicine; Phone Number: 860571-86006246; Email: huanghell@163.com
• Study Contact Backup: Name: Guo-sheng Fu, Doctor of Philosopy; Phone Number: 860571-86006490; Email: fugs64@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo 75mg po per day for 12 months
Experimental: clopidogrel	Drug: clopidogrel; clopidogrel 75 mg po per day for 12 months
Experimental: steply discontinued clopidogrel	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
death	one year
myocardial infarction	one year
any repeat revascularization	one year
strokes	one year
dialysis/hemofiltration	one year
bleeding events	one year

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: bleeding; dual antiplatelet therapy; major adverse cardiac events; sirolimus drug-eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: SRRSH-CVD-001