Table 4. Phase 3 trials of new... | American Society of Hematology

Table 4.

Phase 3 trials of new anticoagulants for secondary prevention of VTE

							Results
Drug	Study	No. of patients	Pop.	Regimen	Control	Outcome measure	Outcome measure	Major bleeding
Fondaparinux	MATISSE-DVT³⁹	2205	Acute DVT	7.5 mg SC OD ≥ 5 d, then warfarin × 3 mo*	Enoxaparin 1 mg/kg bid SC ≥ 5 d then warfarin × 3 mo	Recurrent VTE × 3 mo	Fond: 43/1098 (3.9%)	Fond: 1.1%†
							Enox: 45/1107 (4.1%)	Enox: 1.2%
							NI	NS
	MATISSE-PE⁴⁰	2213	Acute PE	7.5 mg SC OD ≥ 5 d then warfarin × 3 mo*	IV UFH (open-label) ≥ 5 d then warfarin × 3 mo	Recurrent VTE × 3 mo	Fond: 42/1103 (3.8%)	Fond: 14/1103 (1.3%)
							UFH: 56/1110 (5.0%)	UFH: 12/1110 (1.1%)
							NI	NS
Ximelagatran	THRIVE-III⁴¹	1233	VTE following 6 mo standard therapy	Ximelagatran 36 mg bid × 18 mo	Placebo × 18 mo	Recurrent VTE × 18 mo	Xim: 12/612 (2.8%)‡	Xim: 6/612 (1.1%)‡
							Placebo: 71/611 (12.6%)	Placebo: 5/611 (1.3%)
							P = .001	NS
	THRIVE-II/V⁴²	2491	Acute DVT	Ximelagatran 36 mg bid × 6 mo	Enoxaparin 1 mg/kg bid followed with warfarin INR 2-3.0 × 6 mo	Recurrent VTE × 6 mo	Xim: 26/1241 (2.1%)‡	Xim: 14/1241 (1.3%)‡
							Warfarin: 24/1250 (2.0%)	Warfarin: 25/1250 (2.2%)
							NI	NS

							Results
Drug	Study	No. of patients	Pop.	Regimen	Control	Outcome measure	Outcome measure	Major bleeding
Fondaparinux	MATISSE-DVT³⁹	2205	Acute DVT	7.5 mg SC OD ≥ 5 d, then warfarin × 3 mo*	Enoxaparin 1 mg/kg bid SC ≥ 5 d then warfarin × 3 mo	Recurrent VTE × 3 mo	Fond: 43/1098 (3.9%)	Fond: 1.1%†
							Enox: 45/1107 (4.1%)	Enox: 1.2%
							NI	NS
	MATISSE-PE⁴⁰	2213	Acute PE	7.5 mg SC OD ≥ 5 d then warfarin × 3 mo*	IV UFH (open-label) ≥ 5 d then warfarin × 3 mo	Recurrent VTE × 3 mo	Fond: 42/1103 (3.8%)	Fond: 14/1103 (1.3%)
							UFH: 56/1110 (5.0%)	UFH: 12/1110 (1.1%)
							NI	NS
Ximelagatran	THRIVE-III⁴¹	1233	VTE following 6 mo standard therapy	Ximelagatran 36 mg bid × 18 mo	Placebo × 18 mo	Recurrent VTE × 18 mo	Xim: 12/612 (2.8%)‡	Xim: 6/612 (1.1%)‡
							Placebo: 71/611 (12.6%)	Placebo: 5/611 (1.3%)
							P = .001	NS
	THRIVE-II/V⁴²	2491	Acute DVT	Ximelagatran 36 mg bid × 6 mo	Enoxaparin 1 mg/kg bid followed with warfarin INR 2-3.0 × 6 mo	Recurrent VTE × 6 mo	Xim: 26/1241 (2.1%)‡	Xim: 14/1241 (1.3%)‡
							Warfarin: 24/1250 (2.0%)	Warfarin: 25/1250 (2.2%)
							NI	NS

Pop. indicates population.

UFH indicates unfractionated heparin

Fondaparinux given in weight-adjusted doses (5.0 mg if < 50 kg and 10.0 mg if weight > 100 kg).

Raw data unavailable.

Estimated cumulative risk.