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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232830
First received: October 4, 2005
Last updated: September 15, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: drug-eluting stent
Device: bare-metal stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

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

Enrollment: 715
Study Start Date: October 2003
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232830

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00232830     History of Changes
Other Study ID Numbers: EC03-03
Study First Received: October 4, 2005
Last Updated: September 15, 2009
Health Authority: France: Institutional Ethical Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014