TABLE 2.

Phase II and III Clinical Trials Using Dabigatran

Trial Name	Indication	Dabigatran Dose	Comparator	Treatment Duration	Thrombotic Outcome	Major Bleeding
PETRO44 Phase II	Nonvalvular atrial fibrillation	50 mg, 150 mg or 300 mg BID	Warfarin (INR 2Y3)	12 wk	Stroke and systemic embolism 50 mg: 1.7% 150 mg: 0% 300 mg: 0% Warfarin: 0%	50 mg: 0% 150 mg: 0% 300 mg: 0% Warfarin: 0%
RE-LY1 Phase III	Nonvalvular atrial fibrillation	110 mg or 150 mg BID	Warfarin (INR 2Y3)	Median follow-up 2 y	Stroke and systemic embolism 110 mg: 1.53%/y‡ 150 mg: 1.11%/y* Warfarin: 1.69%/y	110 mg: 2.71%/y* 150 mg: 3.11%/y Warfarin: 3.36%/y
RE-DEEM5 Phase II	Secondary prevention after ACS	50 mg, 75 mg, 110 mg, 150 mg BID	Placebo	6 mo	CV death, MI, or stroke 50 mg BID: 4.6% 75 mg BID: 4.9% 110 mg BID: 3.0% 150 mg BID: 3.5% placebo: 3.8%	50 mg BID: 0.8% 75 mg BID: 0.3% 110 mg BID: 2.0%† 150 mg BID: 1.2%† placebo: 0.5%
BISTRO I45 Phase II	VTE prevention after THR	Dose escalation 12.5Y300 mg twice daily, 150 mg or 300 mg/d	N/A	6Y10 d	All VTE 12.5 mg BID: 20.8% 25 mg BID: 9.5% 50 mg BID: 14.8% 100 mg BID: 19.4% 150 mg Daily: 9.1% 150 mg BID: 9.5% 200 mg BID: 19.0% 300 mg Daily: 0%	0% in all groups
BISTRO II46 Phase II	VTE prevention after THR or TKR	50 mg, 150 mg, or 225 mg twice daily, 300 mg/d	Enoxaparin 40 mg/d	6Y10 d	All VTE 50 mg BID: 28.5% 150 mg BID: 17.4%* 300 mg/d: 16.6%* 225 mg BID: 13.1%* Enoxaparin: 24%	50 mg BID: 0.3%* 150 mg BID: 4.1% 300 mg/d: 4.7% 225 mg BID: 3.8% Enoxaparin: 2%
RE-MODEL47 Phase III	VTE prevention after TKR	150 mg or 220 mg/d	Enoxaparin 40 mg/d	6Y10 d	VTE and all-cause mortality 150 mg: 40.5%‡ 220 mg: 36.4%‡ Enoxaparin: 37.7%	150 mg: 1.3% 220 mg: 1.5% Enoxaparin: 1.3%
RE-NOVATE48 Phase III	VTE prevention after THR	150 mg or 220 mg/d	Enoxaparin 40 mg/d	28Y35 d	VTE and all-cause mortality 150 mg: 8.6%‡ 220 mg: 6%‡ Enoxaparin: 6.7%	150 mg: 1.3% 220 mg: 2% Enoxaparin: 1.6%
RE-MOBILIZE49 Phase III	VTE prevention after TKR	150 mg or 220 mg/d	Enoxaparin 30 mg BID	12Y15 d	VTE and all-cause mortality 150 mg: 34%† 220 mg: 31%† Enoxaparin: 25%	150 mg: 0.6% 220 mg: 0.6% Enoxaparin: 1.4%
RE-NOVATE II7 Phase III	VTE prevention after THR	220 mg/d	Enoxaparin 40 mg/d	208Y35 d	VTE and all-cause mortality 220 mg: 7.7%‡ Enoxaparin: 8.8%	220 mg: 1.4% Enoxaparin: 0.9%
RE-COVER8 Phase III	Acute VTE treatment	150 mg BID	Warfarin (INR 2Y3)	6 mo	Recurrent VTE Dabigatran: 2.4%‡ Warfarin: 2.1%	Dabigatran: 1.6% Warfarin: 1.9%
RE-MEDY Phase III	Secondary VTE prophylaxis	150 mg BID	Warfarin (INR 2Y3)	18 mo	Not reported	Not reported

^*Statistically significant superiority demonstrated over comparator.

^†Statistically significant inferiority demonstrated over comparator.

^‡Statistically significant noninferiority demonstrated to comparator.

ACS, acute coronary syndrome; TKR, total knee replacement; THR, total hip replacement.