Back to resultsEffect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation (EASTS)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
clopidogrel
placebo
clopidogrel and placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring dual antiplatelet therapy, sirolimus drug-eluting stent, major adverse cardiac events, bleeding
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
clopidogrel
placebo
steply discontinued clopidogrel
Arm Description
Outcomes
Primary Outcome Measures
all cause mortality
nonfatal myocardial infarction
clinical-driven target vessel revascularization
cardiac death
stent thrombosis
Secondary Outcome Measures
death
myocardial infarction
any repeat revascularization
strokes
dialysis/hemofiltration
bleeding events
Full Information
NCT ID
NCT01233167
First Posted
November 1, 2010
Last Updated
July 19, 2011
Sponsor
Sir Run Run Shaw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01233167
Brief Title
Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
Acronym
EASTS
Official Title
Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sir Run Run Shaw Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
dual antiplatelet therapy, sirolimus drug-eluting stent, major adverse cardiac events, bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clopidogrel
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
steply discontinued clopidogrel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
clopidogrel 75 mg po per day for 12 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 75mg po per day for 12 months
Intervention Type
Drug
Intervention Name(s)
clopidogrel and placebo
Intervention Description
clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year
Title
nonfatal myocardial infarction
Time Frame
one year
Title
clinical-driven target vessel revascularization
Time Frame
one year
Title
cardiac death
Time Frame
one year
Title
stent thrombosis
Time Frame
one year
Secondary Outcome Measure Information:
Title
death
Time Frame
one year
Title
myocardial infarction
Time Frame
one year
Title
any repeat revascularization
Time Frame
one year
Title
strokes
Time Frame
one year
Title
dialysis/hemofiltration
Time Frame
one year
Title
bleeding events
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, Doctor of Medicine
Phone
860571-86006246
Email
huanghell@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-sheng Fu, Doctor of Philosopy
Phone
860571-86006490
Email
fugs64@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
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