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)

October 28, 2008 updated by: Beijing Chao Yang Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.0-Sep 10, 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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