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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Sir Run Run Shaw Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier:
NCT01233167
First received: November 1, 2010
Last updated: July 19, 2011
Last verified: October 2010
  Purpose

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 Intervention
Coronary Artery Disease
Drug: clopidogrel
Drug: placebo
Drug: clopidogrel and placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sir Run Run Shaw Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • nonfatal myocardial infarction [ Time Frame: one year ] [ Designated as safety issue: No ]
  • clinical-driven target vessel revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • cardiac death [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: one year ] [ Designated as safety issue: No ]
  • any repeat revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • strokes [ Time Frame: one year ] [ Designated as safety issue: No ]
  • dialysis/hemofiltration [ Time Frame: one year ] [ Designated as safety issue: No ]
  • bleeding events [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5232
Study Start Date: August 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233167

Contacts
Contact: He Huang, Doctor of Medicine 860571-86006246 huanghell@163.com
Contact: Guo-sheng Fu, Doctor of Philosopy 860571-86006490 fugs64@gmail.com

Sponsors and Collaborators
Sir Run Run Shaw Hospital
  More Information

No publications provided

Responsible Party: Guosheng Fu, director of cardiovascular department, Sir Run Run Shaw Hospital, College of medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT01233167     History of Changes
Other Study ID Numbers: SRRSH-CVD-001
Study First Received: November 1, 2010
Last Updated: July 19, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Sirolimus
Everolimus
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 16, 2014