Back to resultsThe Study to Assess AMI Treated With Balloon Angioplasty. (TYPHOON)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
drug-eluting stent
bare-metal stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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.
Sites / Locations
- HOPITAL COCHIN, René Descartes University
- University of Freiburg, Albert-Ludwigs-Universitätskliniken
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Cypher Sirolimus-eluting Coronary Stent
Bare-metal stent
Outcomes
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.
Secondary Outcome Measures
cardiac death
recurrence of myocardial infarction
revascularization of the target vessel (TVR)
recurrence of ischemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232830
Brief Title
The Study to Assess AMI Treated With Balloon Angioplasty.
Acronym
TYPHOON
Official Title
Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
715 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cypher Sirolimus-eluting Coronary Stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
Bare-metal stent
Intervention Type
Device
Intervention Name(s)
drug-eluting stent
Intervention Description
Cypher Sirolimus-eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
bare-metal stent
Intervention Description
any bare-metal stent brand
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
cardiac death
Time Frame
1, 3, 4 and 5 years post-procedure
Title
recurrence of myocardial infarction
Time Frame
1, 3, 4 and 5 years post-procedure
Title
revascularization of the target vessel (TVR)
Time Frame
1, 3, 4 and 5 years post-procedure
Title
recurrence of ischemia
Time Frame
1, 3, 4 and 5 years post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Spaulding, MD
Organizational Affiliation
HOPITAL COCHIN, René Descartes University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoph Bode, MD
Organizational Affiliation
University of Freiburg, Albert-Ludwigs-Universitätskliniken
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL COCHIN, René Descartes University
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
University of Freiburg, Albert-Ludwigs-Universitätskliniken
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16971716
Citation
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.
Results Reference
result
PubMed Identifier
19527979
Citation
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.
Results Reference
result
PubMed Identifier
21251624
Citation
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.
Results Reference
derived
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The Study to Assess AMI Treated With Balloon Angioplasty.
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