OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Sanofi
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

• Subjects who presented or were admitted to hospital with:

1. Signs and symptoms of AMI

2. Were able to randomize within 12 hours of symptom onset; and-

3. Had definite ECG changes indicating STEMI: persistent ST-elevation (≥0.2mV in two contiguous precordial leads, or ≥0.1mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI.

• Written informed consent

• Able to be randomized within 24 hours of symptom onset

Exclusion Criteria:

• Age <21 years.

• Was currently receiving an oral anticoagulant agent with an INR >1.8.

• Had any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding.

• Had hemorrhagic stroke within the last 12 months.

• Had an indication for anticoagulation other than ACS.

• Pregnant women or women of child-bearing potential who were not using an effective method of contraception.

• Had a co-morbid condition with a life-expectancy <6 months.

• Previous enrollment in one of the fondaparinux ACS trials.

• Participation in another pharmacotherapeutic study within the prior 30 days or was currently receiving an experimental pharmacological agent.

• Had a known allergy to heparin or fondaparinux.

• Had severe renal insufficiency (i.e. serum creatinine ≥3mg/dL or ≥265μmol/L).

• Had >5000IU UFH administered prior to randomization.

• Had LMWH administered prior to randomization.

• Subject had pre-randomization revascularization (PCI) for the index event.

• Subject had pre-randomization rescue PCI.