Table 3. Ximelagatran Phase III trials.... | American Society of Hematology

Table 3.

Ximelagatran Phase III trials.

Major Group	Study Name	Treatment	n	VTE	P	Bleeding	P
Abbreviations: DVT, deep venous thrombosis; NS, not significant; VTE, venous thromboembolism.
^amelagatran 2 mg subcutaneous (SC) immediately pre-op; 3 mg SC the evening of surgery followed by ximelagatran 24 mg po bid
^benoxaparin 40 mg SC 12 hrs pre-op and then daily
^cmelagatran 3 mg SC 4–12 hrs post-op followed by ximelagatran 24 mg po bid
^denoxparin 30 mg SC q12 starting 12–24 hrs post-op
^e24 mg po q12h
^f36 mg po bid
Orthopedic Surgery Prophylaxis
*Melagatran/Ximelagatran (Europe)*
Hip or knee replacement	Express²⁹	melagatran^a
		ximelagatran^e	1141	20.3%	< .001	3.1%	< .001
		enoxaparin^b	1184	26.6%
Hip or knee replacement	Methro III³⁰	melagatran^c
		ximelagatran	1146	31.0%	NS	1.4%	NS
		enoxaparin^b	1122	27.3%		1.7%
*Ximelagatran only (North America)*
Knee replacement	31	ximelagatran^e	276	19.2%	NS	1.7%	NS
		warfarin	261	25.7%		0.9%
Knee replacement	Exult³²	ximelagatran 24^e	614	24.9%		0.8%	NS
		ximelagatran 36^f	629	20.3%	.003	0.8%	NS
		warfarin	608	27.6%		0.7%	NS
Hip replacement	33	ximelagatran^e	782	7.9%	< .05	0.8%	NS
		enoxaparin^d	775	4.6%		0.9%
Other Indications
Group	Study Name	Treatment	n	Stroke and Systemic Emboli	P	Major Bleeding	P
Atrial fibrillation	Sportif III³⁴	ximelagatran^f	1704	1.6%/yr	NS	1.3%/yr	NS
		warfarin	1703	2.3%/yr	NS	1.8%/yr	NS
				Recurrence
DVT treatment	Thrive III³⁵	ximelagatran^e	612	2.0%	< .0001	1.0%	NS
		placebo	611	11.0%		0.8%	NS

Major Group	Study Name	Treatment	n	VTE	P	Bleeding	P
Abbreviations: DVT, deep venous thrombosis; NS, not significant; VTE, venous thromboembolism.
^amelagatran 2 mg subcutaneous (SC) immediately pre-op; 3 mg SC the evening of surgery followed by ximelagatran 24 mg po bid
^benoxaparin 40 mg SC 12 hrs pre-op and then daily
^cmelagatran 3 mg SC 4–12 hrs post-op followed by ximelagatran 24 mg po bid
^denoxparin 30 mg SC q12 starting 12–24 hrs post-op
^e24 mg po q12h
^f36 mg po bid
Orthopedic Surgery Prophylaxis
*Melagatran/Ximelagatran (Europe)*
Hip or knee replacement	Express²⁹	melagatran^a
		ximelagatran^e	1141	20.3%	< .001	3.1%	< .001
		enoxaparin^b	1184	26.6%
Hip or knee replacement	Methro III³⁰	melagatran^c
		ximelagatran	1146	31.0%	NS	1.4%	NS
		enoxaparin^b	1122	27.3%		1.7%
*Ximelagatran only (North America)*
Knee replacement	31	ximelagatran^e	276	19.2%	NS	1.7%	NS
		warfarin	261	25.7%		0.9%
Knee replacement	Exult³²	ximelagatran 24^e	614	24.9%		0.8%	NS
		ximelagatran 36^f	629	20.3%	.003	0.8%	NS
		warfarin	608	27.6%		0.7%	NS
Hip replacement	33	ximelagatran^e	782	7.9%	< .05	0.8%	NS
		enoxaparin^d	775	4.6%		0.9%
Other Indications
Group	Study Name	Treatment	n	Stroke and Systemic Emboli	P	Major Bleeding	P
Atrial fibrillation	Sportif III³⁴	ximelagatran^f	1704	1.6%/yr	NS	1.3%/yr	NS
		warfarin	1703	2.3%/yr	NS	1.8%/yr	NS
				Recurrence
DVT treatment	Thrive III³⁵	ximelagatran^e	612	2.0%	< .0001	1.0%	NS
		placebo	611	11.0%		0.8%	NS