drugset / Trial / NCT00064428

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

NCT00064428 ↗

Phase 3 Completed 12092 enrolled GlaxoSmithKline Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2003-08
Primary completion
2006-02
Completion
2006-02

Outcome

Met primary endpoint

paper Death or reinfarction at 30 days was significantly reduced from 677 (11.2%) of 6056 patients in the control group to 585 (9.7%) PMID 16537725 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fondaparinux Other / unclassified 2.5 mg Subcutaneous
Subject unfractionated heparin Unknown 12 iu/kg Intravenous

Indications