Table 6. Phase 3 trials of new... | American Society of Hematology

Table 6.

Phase 3 trials of new anticoagulants for atrial fibrillation

							Main results
Anticoagulant	Study	No. of patients	Pop.	Regimen	Control	Outcome measure	Outcome measure	Major bleeding
Ximelagatran	SPORTIF-III⁹³	3407	Atrial fibrillation	36 mg PO bid	Warfarin INR 2-3.0	All strokes and systemic embolism (21 mo)	Xim: 40/1703 (1.6%) Warfarin: 56/1704 (2.3%) NI	Xim: 29/1703 (1.3%) Warfarin: 41/1703 (1.8%) NS
	SPORTIF-V⁹⁴	3922	Atrial fibrillation	36 mg orally bid	Warfarin INR 2-3.0	All strokes and systemic embolism (21 mo)	Xim: 51/1960 (1.6%) Warfarin: 37/1962 (1.2%) NI*	Xim: 2.4%† Warfarin: 3.1% NS

							Main results
Anticoagulant	Study	No. of patients	Pop.	Regimen	Control	Outcome measure	Outcome measure	Major bleeding
Ximelagatran	SPORTIF-III⁹³	3407	Atrial fibrillation	36 mg PO bid	Warfarin INR 2-3.0	All strokes and systemic embolism (21 mo)	Xim: 40/1703 (1.6%) Warfarin: 56/1704 (2.3%) NI	Xim: 29/1703 (1.3%) Warfarin: 41/1703 (1.8%) NS
	SPORTIF-V⁹⁴	3922	Atrial fibrillation	36 mg orally bid	Warfarin INR 2-3.0	All strokes and systemic embolism (21 mo)	Xim: 51/1960 (1.6%) Warfarin: 37/1962 (1.2%) NI*	Xim: 2.4%† Warfarin: 3.1% NS

Event rates (% per patient-year).

Results published in abstract only, raw data unavailable.