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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01233167
Recruitment Status : Unknown
Verified October 2010 by Sir Run Run Shaw Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2010
Last Update Posted : July 20, 2011
Information provided by:
Sir Run Run Shaw Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: clopidogrel Drug: placebo Drug: clopidogrel and placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 5232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation
Study Start Date : August 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: clopidogrel Drug: clopidogrel
clopidogrel 75 mg po per day for 12 months
Placebo Comparator: placebo Drug: placebo
placebo 75mg 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

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]
  2. nonfatal myocardial infarction [ Time Frame: one year ]
  3. clinical-driven target vessel revascularization [ Time Frame: one year ]
  4. cardiac death [ Time Frame: one year ]
  5. stent thrombosis [ Time Frame: one year ]

Secondary Outcome Measures :
  1. death [ Time Frame: one year ]
  2. myocardial infarction [ Time Frame: one year ]
  3. any repeat revascularization [ Time Frame: one year ]
  4. strokes [ Time Frame: one year ]
  5. dialysis/hemofiltration [ Time Frame: one year ]
  6. bleeding events [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233167

Contact: He Huang, Doctor of Medicine 860571-86006246
Contact: Guo-sheng Fu, Doctor of Philosopy 860571-86006490

Sponsors and Collaborators
Sir Run Run Shaw Hospital

Responsible Party: Guosheng Fu, director of cardiovascular department, Sir Run Run Shaw Hospital, College of medicine, Zhejiang University Identifier: NCT01233167     History of Changes
Other Study ID Numbers: SRRSH-CVD-001
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: October 2010

Keywords provided by Sir Run Run Shaw Hospital:
dual antiplatelet therapy
sirolimus drug-eluting stent
major adverse cardiac events

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents