Status:
COMPLETED
Michelangelo - Oasis 5
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
University of Chicago
Organon
Conditions:
Thromboembolism
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
Study Objectives PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9...
Detailed Description
This is a double-blind, double-dummy, randomized, parallel-group, controlled trial to compare the safety and efficacy of fondaparinux and enoxaparin in subjects with UA/NSTEMI (unstable angina/non ST ...
Eligibility Criteria
Inclusion
- Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
- Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
- At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
- Written informed consent
Exclusion
- Age \< 21 years
- Any contraindication to low molecular weight heparin
- Hemorrhagic stroke within the last 12 months
- Indication for anticoagulation other than ACS.
- Pregnancy or women of childbearing potential who are not using an effective method of contraception
- Co-morbid condition with life expectancy less than 6 months
- Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
20078 Patients enrolled
Trial Details
Trial ID
NCT00139815
Start Date
April 1 2003
End Date
December 1 2005
Last Update
September 15 2016
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