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)

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Device: Drug eluting coronary stent system

• Study Type: Interventional
• Enrollment (Anticipated): 1020
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Beijing Chaoyang Hospital Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	at 12 months

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: LeFeng Wang, MD, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Estimate): October 29, 2008
• Last Update Submitted That Met QC Criteria: October 28, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: ST elevation myocardial infarction; Drug eluting stents
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction; Emergencies
• Other Study ID Numbers: Version 1.0-Sep 10, 2008