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

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: Coronary Artery Disease
• Intervention / Treatment: Device: drug-eluting stent; Device: 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: Interventional
• Enrollment (Actual): 715
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • HOPITAL COCHIN, René Descartes University
• Germany
  • Freiburg, Germany, 79106
    • University of Freiburg, Albert-Ludwigs-Universitätskliniken

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

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.	1 and 6 months and at 1, 3, 4, and 5 years post-procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
cardiac death	1, 3, 4 and 5 years post-procedure
recurrence of myocardial infarction	1, 3, 4 and 5 years post-procedure
revascularization of the target vessel (TVR)	1, 3, 4 and 5 years post-procedure
recurrence of ischemia	1, 3, 4 and 5 years post-procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• 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

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

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: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: EC03-03