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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. Identifier: NCT00232830
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : September 16, 2009
Information provided by:
Cordis Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: drug-eluting stent Device: bare-metal stent Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
Study Start Date : October 2003
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Cypher Sirolimus-eluting Coronary Stent
Device: drug-eluting stent
Cypher Sirolimus-eluting Coronary Stent

Active Comparator: 2
Bare-metal stent
Device: bare-metal stent
any bare-metal stent brand

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. cardiac death [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
  2. recurrence of myocardial infarction [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
  3. revascularization of the target vessel (TVR) [ Time Frame: 1, 3, 4 and 5 years post-procedure ]
  4. recurrence of ischemia [ Time Frame: 1, 3, 4 and 5 years post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232830

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HOPITAL COCHIN, René Descartes University
Paris, France, 75014
University of Freiburg, Albert-Ludwigs-Universitätskliniken
Freiburg, Germany, 79106
Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: Christian Spaulding, MD HOPITAL COCHIN, René Descartes University
Principal Investigator: Christoph Bode, MD University of Freiburg, Albert-Ludwigs-Universitätskliniken

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Hans-Peter Stoll, Cordis Identifier: NCT00232830    
Other Study ID Numbers: EC03-03
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases