An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.

NCT00064428 Phase 3 COMPLETED

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.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	12092
Start date	2003-08
Completion	2006-02

Conditions

• Thromboembolism

Interventions

• fondaparinux - UFH not indicated
• Control - UFH not indicated
• Fondaparinux - UFH indicated
• Control - UFH

Primary outcomes

• Death or recurrent myocardial infarction — up to day 30
  the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction
• Severe hemorrhage — up to Day 9
  Severe hemorrhage (modified TIMI criteria)