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
Sponsor:
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
  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:

  1. The patient must be ≥18 years and ≤75 of age.
  2. 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
  3. Symptoms ≥ 30 min and ≤12 hours
  4. The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form"
  5. 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
  6. The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria:

  1. Pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
  2. Systemic (intravenous) Sirolimus use within 12 months.
  3. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
  4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  6. Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
  7. Fibrinolytic therapy for current MI treatment
  8. Previous coronary intervention on target vessel or post-CABG vessel disease
  9. Transplant patients
  10. Patients with EF<25%
  11. Patients with cardiogenic shock; with a life expectancy shorter than 12 months
  12. Severe kidney dysfunction: Creatinine level ≥2.0mg/dL or dependence on dialysis.
  13. Severe hepatic dysfunction (AST and ALT ≥ 3 times upper normal reference values).
  14. 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.
  15. 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 April 16, 2014