The Study to Assess AMI Treated With Balloon Angioplasty.

Coronary Artery Disease Clinical Trial

— TYPHOON  

Official title:

Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232830
• Other study ID #: EC03-03
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: September 15, 2009
• Start date: October 2003
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent
Cypher Sirolimus-eluting Coronary Stent
• bare-metal stent
any bare-metal stent brand

Locations

Country	Name	City	State
France	HOPITAL COCHIN, René Descartes University	Paris
Germany	University of Freiburg, Albert-Ludwigs-Universitätskliniken	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (2)

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 interventi — View Citation

Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrié 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 E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	cardiac death		1, 3, 4 and 5 years post-procedure	Yes
Secondary	recurrence of myocardial infarction		1, 3, 4 and 5 years post-procedure	Yes
Secondary	revascularization of the target vessel (TVR)		1, 3, 4 and 5 years post-procedure	Yes
Secondary	recurrence of ischemia		1, 3, 4 and 5 years post-procedure	Yes