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

Coronary Artery Disease Clinical Trial

— CREST-MI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00781716
• Other study ID #: Version 1.0-Sep 10, 2008
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2008
• Last updated: October 28, 2008
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: October 2008
• Source: Beijing Chao Yang Hospital
• Contact: LeFeng Wang, MD
• Phone: 86-13601255020
• Email: CrestMI[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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 myocardial infarction in China.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1020
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Drug eluting coronary stent system
Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital Heart Center	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes