Coronary Artery DiseaseEASTSNCT01233167
Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
A study testing clopidogrel in people with Coronary Artery Disease, run by Sir Run Run Shaw Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,232 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- clopidogrel, placebo, clopidogrel and placebo
- Keywords
- dual antiplatelet therapy, sirolimus drug-eluting stent, major adverse cardiac events, bleeding
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
clopidogrel 75 mg po per day for 12 months
placeboDrug
placebo 75mg po per day for 12 months
clopidogrel and placeboDrug
clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel | Experimental | Not described Receives: Drug: clopidogrel |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| steply discontinued clopidogrel | Experimental | Not described Receives: Drug: clopidogrel and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
nonfatal myocardial infarction
Measured: one year
clinical-driven target vessel revascularization
Measured: one year
cardiac death
Measured: one year
stent thrombosis
Measured: one year
Secondary outcomes (6)
death
Measured: one year
myocardial infarction
Measured: one year
any repeat revascularization
Measured: one year
strokes
Measured: one year
dialysis/hemofiltration
Measured: one year
bleeding events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5,232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233167
- Sponsor's protocol ID
- SRRSH-CVD-001
- Acronym
- EASTS
- Status last verified
- Oct 2010
- First submitted
- 1 Nov 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT01233167
- Acronym / sponsor ID
- EASTS / SRRSH-CVD-001
- Conditions
- Coronary Artery Disease
- Keywords
- dual antiplatelet therapy, sirolimus drug-eluting stent, major adverse cardiac events, bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,232 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | Experimental | Drug: clopidogrel |
| placebo | Placebo comparator | Drug: placebo |
| steply discontinued clopidogrel | Experimental | Drug: clopidogrel and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelclopidogrel 75 mg po per day for 12 months | Drug | clopidogrel |
| placeboplacebo 75mg po per day for 12 months | Drug | placebo |
| clopidogrel and placeboclopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months | Drug | steply discontinued clopidogrel |
Primary outcome
all cause mortality
Time frame: one year
nonfatal myocardial infarction
Time frame: one year
clinical-driven target vessel revascularization
Time frame: one year
cardiac death
Time frame: one year
stent thrombosis
Time frame: one year
6 secondary outcomes
death
Time frame: one year
myocardial infarction
Time frame: one year
any repeat revascularization
Time frame: one year
strokes
Time frame: one year
dialysis/hemofiltration
Time frame: one year
bleeding events
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing clopidogrel in people with Coronary Artery Disease, run by Sir Run Run Shaw Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, Doctor of Medicine (860571-86006246, huanghell@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.