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

NCT00781716 | Unknown

• 1 other identifier: Version 1.0-Sep 10, 2008
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Keywords

ST elevation myocardial infarction; Drug eluting stents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cypher Stent

ACTIVE COMPARATOR

Cypher Sirolimus-Eluting Coronary Stent System

Device: Drug eluting coronary stent system

Endeavor Stent

ACTIVE COMPARATOR

Endeavor Zotarolimus-Eluting Coronary Stent System

Device: Drug eluting coronary stent system

Interventions

Drug eluting coronary stent system DEVICE

Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System

Cypher Stent; Endeavor Stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital Heart Center

Beijing, BJ, 10000, China

Location

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• LeFeng Wang, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeFeng Wang, MD

CONTACT

86-13601255020; CrestMI@gmail.com

Caihong Wang

CONTACT

86-13001980897; crest_mi@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 29, 2008

Record last verified: 2008-10

Locations

CN (1)