Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

Phase 3

Completed

• Conditions: Myocardial Infarction; Acute ST-Segment Elevation

• Registration Number: NCT00077792
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2004-02-12
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-17
• Last Update Posted: 2009-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20506

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality and non-fatal myocardial re-infarction

Secondary Outcome Measures

Name	Time	Method
Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke

Trial Locations

Locations (5)

sanofi-aventis administrative Office; 🇦🇷 Buenos Aires, Argentina

Sanofi- Aventis Administrative Office; 🇫🇷 Paris, France

sanofi-aventis Australia & New Zealand administrative office; 🇦🇺 Macquarie Park, Australia

Sanofi-Aventis Administrative Office; 🇺🇾 Montevideo, Uruguay

Sanofi-aventis adminsitrative office; 🇬🇧 Guildford Surrey, United Kingdom