The Study to Assess AMI Treated With Balloon Angioplasty. (TYPHOON)
September 15, 2009 updated by: Cordis Corporation
Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
715
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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:
- ST segment elevation >=1mm in standard leads and >=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
- New or presumably new left bundle branch block (LBBB)
- 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:
- Killip class > 2 upon arrival to the cath-lab;
- Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
- Documented left ventricular ejection fraction <=30%;
- Target lesion is located in an arterial or venous by-pass graft;
- ECG documented evidence of prior myocardial infarction;
- Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Cypher Sirolimus-eluting Coronary Stent
|
Cypher Sirolimus-eluting Coronary Stent
|
|
Active Comparator: 2
Bare-metal stent
|
any bare-metal stent brand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
1 and 6 months and at 1, 3, 4, and 5 years post-procedure.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
cardiac death
Time Frame: 1, 3, 4 and 5 years post-procedure
|
1, 3, 4 and 5 years post-procedure
|
|
recurrence of myocardial infarction
Time Frame: 1, 3, 4 and 5 years post-procedure
|
1, 3, 4 and 5 years post-procedure
|
|
revascularization of the target vessel (TVR)
Time Frame: 1, 3, 4 and 5 years post-procedure
|
1, 3, 4 and 5 years post-procedure
|
|
recurrence of ischemia
Time Frame: 1, 3, 4 and 5 years post-procedure
|
1, 3, 4 and 5 years post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Spaulding, MD, HOPITAL COCHIN, René Descartes University
- Principal Investigator: Christoph Bode, MD, University of Freiburg, Albert-Ludwigs-Universitätskliniken
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C; TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006 Sep 14;355(11):1093-104. doi: 10.1056/NEJMoa062006.
- Rozenman Y, Witzling V, Tamari I, Turkisher V, Kriviski M, Bode C, Henry P, Teiger E, Cebrian A, Stoll HP, Spaulding C. Impact of stent length on restenosis in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: analysis based on data from the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). EuroIntervention. 2009 Jun;5(2):219-23. doi: 10.4244/eijv5i2a34.
- Spaulding C, Teiger E, Commeau P, Varenne O, Bramucci E, Slama M, Beatt K, Tirouvanziam A, Polonski L, Stella PR, Clugston R, Fajadet J, de Boisgelin X, Bode C, Carrie D, Erglis A, Merkely B, Hosten S, Cebrian A, Wang P, Stoll HP, Henry P. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Cardiovasc Interv. 2011 Jan;4(1):14-23. doi: 10.1016/j.jcin.2010.10.007.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
October 4, 2005
First Submitted That Met QC Criteria
October 4, 2005
First Posted (Estimate)
October 5, 2005
Study Record Updates
Last Update Posted (Estimate)
September 16, 2009
Last Update Submitted That Met QC Criteria
September 15, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC03-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.