Myocardial InfarctionCREST-MINCT00781716
Safety and Efficacy Study of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction (STEMI) and Analysis of Current Status of Emergency PCI Green Channel for STEMI Patients in China
A study testing Drug eluting coronary stent system in people with Myocardial Infarction and Coronary Artery Disease, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Drug eluting coronary stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to May 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be ≥18 years and ≤75 of age.
- Prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) ST-segment elevation ≥ at least 2 leads, with reciprocal ST-segment elevation ≥ 0.05mv and precordial leads ST-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
- Symptoms ≥ 30 min and ≤12 hours
- The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form"
- All lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more Cypher® Sirolimus-Eluting Coronary Stent System or Endeavor® Zotarolimus-Eluting Coronary Stent
- The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.
Who cannot join
- Pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
- Systemic (intravenous) Sirolimus use within 12 months.
- Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
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- Fibrinolytic therapy for current MI treatment
- Previous coronary intervention on target vessel or post-CABG vessel disease
- Transplant patients
- Patients with EF<25%
- Patients with cardiogenic shock; with a life expectancy shorter than 12 months
- Severe kidney dysfunction: Creatinine level ≥2.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT ≥ 3 times upper normal reference values).
- The patient is currently, and during the CREST-MI Study, participating in another investigational device or drug study that clinically interferes with the CREST-MI study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the CREST-MI Study once.
- Severe tortuous or calcified vessel; stent can not or has difficulty to go through; blood vessel diameter is smaller than the minimum stent diameter available; patients unsuitable for stent implantation.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chaoyang Hospital Heart Center
Beijing, BJ, 10000
LeFeng Wang, MD, 86-13601255020, CrestMI@gmail.com
About this study
Official title: Comparison of Safety and Efficacy of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction and Analysis of Current Status of Emergency PCI Green Channel for Patients With ST Elevation Myocardial Infarction in China
This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation myocardial infarction in China.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- Drug eluting coronary stent system
- Keywords
- ST elevation myocardial infarction, Drug eluting stents
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting coronary stent systemDevice
Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System
| Study group | Role | What they receive |
|---|---|---|
| Cypher Stent | Active comparator | Cypher Sirolimus-Eluting Coronary Stent System Receives: Device: Drug eluting coronary stent system |
| Endeavor Stent | Active comparator | Endeavor Zotarolimus-Eluting Coronary Stent System Receives: Device: Drug eluting coronary stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events defined as death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA or CABG)
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- LeFeng Wang, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781716
- Sponsor's protocol ID
- Version 1.0-Sep 10, 2008
- Acronym
- CREST-MI
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction and Analysis of Current Status of Emergency PCI Green Channel for Patients With ST Elevation Myocardial Infarction in China
- ClinicalTrials.gov ID
- NCT00781716
- Acronym / sponsor ID
- CREST-MI / Version 1.0-Sep 10, 2008
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- ST elevation myocardial infarction, Drug eluting stents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 29 Oct 2008 (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.
This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation myocardial infarction in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cypher Stent | Active comparator | Device: Drug eluting coronary stent systemCypher Sirolimus-Eluting Coronary Stent System |
| Endeavor Stent | Active comparator | Device: Drug eluting coronary stent systemEndeavor Zotarolimus-Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must be ≥18 years and ≤75 of age.
- Prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) ST-segment elevation ≥ at least 2 leads, with reciprocal ST-segment elevation ≥ 0.05mv and precordial leads ST-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
- Symptoms ≥ 30 min and ≤12 hours
- The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form"
- All lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more Cypher® Sirolimus-Eluting Coronary Stent System or Endeavor® Zotarolimus-Eluting Coronary Stent
Key exclusion criteria (15 listed)
- Pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
- Systemic (intravenous) Sirolimus use within 12 months.
- Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 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 |
|---|---|---|
| Drug eluting coronary stent systemCypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System | Device | Cypher Stent, Endeavor Stent |
Primary outcome
Major Adverse Cardiac Events defined as death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA or CABG)
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
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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.
LeFeng Wang, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting coronary stent system in people with Myocardial Infarction and Coronary Artery Disease, run by Beijing Chao Yang Hospital at 1 site in China.
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 6 inclusion and 15 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 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 LeFeng Wang, MD (86-13601255020, CrestMI@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events defined as death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA or CABG) (time frame: at 12 months). 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 29 Oct 2008.