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01
Overview
Phase 4, randomised, open-label trial in thrombosis comparing Heparin/Warfarin with ASA (2 arms). Primary endpoint: Warfarin vs ASA in prevention of thrombosis at 2 years. Started Aug 1998; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Heparin/Warfarin
Warfarin therapy (likely with Heparin bridge)
ASA
Acetylsalicylic Acid therapy
03
Who it enrols
Children scheduled for a Fontan procedure without contraindications to anticoagulation.
04
Endpoints
Primary
Warfarin vs ASA in prevention of thrombosis
Secondary
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan
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