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The Study to Assess AMI Treated With Balloon Angioplasty. (TYPHOON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00232830
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : September 16, 2009
Sponsor:
Information provided by:
Cordis Corporation

Tracking Information
First Submitted Date  ICMJE October 4, 2005
First Posted Date  ICMJE October 5, 2005
Last Update Posted Date September 16, 2009
Study Start Date  ICMJE October 2003
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. [ Time Frame: 1 and 6 months and at 1, 3, 4, and 5 years post-procedure. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 1 year post-procedure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
  • cardiac death [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
  • recurrence of myocardial infarction [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
  • revascularization of the target vessel (TVR) [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
  • recurrence of ischemia [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study to Assess AMI Treated With Balloon Angioplasty.
Official Title  ICMJE Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
Brief Summary The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
Detailed Description

This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents.

Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: drug-eluting stent
    Cypher Sirolimus-eluting Coronary Stent
  • Device: bare-metal stent
    any bare-metal stent brand
Study Arms  ICMJE
  • Experimental: 1
    Cypher Sirolimus-eluting Coronary Stent
    Intervention: Device: drug-eluting stent
  • Active Comparator: 2
    Bare-metal stent
    Intervention: Device: bare-metal stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2007)
715
Original Enrollment  ICMJE
 (submitted: October 4, 2005)
700
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:

    1. ST segment elevation >=1mm in standard leads and >=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
    2. New or presumably new left bundle branch block (LBBB)
  2. The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;

Exclusion Criteria:

  1. Killip class > 2 upon arrival to the cath-lab;
  2. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
  3. Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
  4. Documented left ventricular ejection fraction <=30%;
  5. Target lesion is located in an arterial or venous by-pass graft;
  6. ECG documented evidence of prior myocardial infarction;
  7. Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00232830
Other Study ID Numbers  ICMJE EC03-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Hans-Peter Stoll, Cordis
Study Sponsor  ICMJE Cordis Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Spaulding, MD HOPITAL COCHIN, René Descartes University
Principal Investigator: Christoph Bode, MD University of Freiburg, Albert-Ludwigs-Universitätskliniken
PRS Account Cordis Corporation
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP