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 (CREST-MI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Beijing Chao Yang Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Beijing Chao Yang Hospital
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT00781716
First received: October 28, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction Coronary Artery Disease |
Device: Drug eluting coronary stent system |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Beijing Chao Yang Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1020 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cypher Stent
Cypher Sirolimus-Eluting Coronary Stent System
|
Device: Drug eluting coronary stent system
Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System
|
|
Active Comparator: Endeavor Stent
Endeavor Zotarolimus-Eluting Coronary Stent System
|
Device: Drug eluting coronary stent system
Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781716
Contacts
| Contact: LeFeng Wang, MD | 86-13601255020 | CrestMI@gmail.com |
| Contact: Caihong Wang | 86-13001980897 | crest_mi@sina.com |
Locations
| China, Beijing | |
| Beijing Chaoyang Hospital Heart Center | Not yet recruiting |
| Beijing, Beijing, China, 10000 | |
| Contact: LeFeng Wang, MD 86-13601255020 CrestMI@gmail.com | |
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
| Principal Investigator: | LeFeng Wang, MD | Chaoyang Hospital |
More Information
No publications provided
| Responsible Party: | Dr. LeFeng Wang/Director of the Cath Lab, Beijing Chao Yang Hospital Heart Center |
| ClinicalTrials.gov Identifier: | NCT00781716 History of Changes |
| Other Study ID Numbers: | Version 1.0-Sep 10, 2008 |
| Study First Received: | October 28, 2008 |
| Last Updated: | October 28, 2008 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Beijing Chao Yang Hospital:
|
ST elevation myocardial infarction Drug eluting stents |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Emergencies Infarction Myocardial Infarction Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Disease Attributes Pathologic Processes Ischemia |
Necrosis Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013