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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014