CREST-MI: 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

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00781716

Collaborator

(none)

1,020

Enrollment

Location

Arms

30.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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 myocardial infarction in China.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Coronary Artery Disease	Device: Drug eluting coronary stent system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1020 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

May 1, 2011

Anticipated Study Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

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) [at 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.