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. Author manuscript; available in PMC: 2015 Jul 27.
Published in final edited form as: J Trauma Acute Care Surg. 2012 Oct;73(4):983–992. doi: 10.1097/TA.0b013e318265cf9e

TABLE 4.

Phase II and III Clinical Trials of Apixaban

Trial Name Indication Dose Comparator Treatment Duration Thrombotic Outcome Major Bleeding
AVERROES25
Phase III		 Nonvalvular atrial fibrillation 5 mg BID Aspirin 81Y324 mg Median follow-up 1.1 y Stroke or systemic embolism Apixaban: 1.6%/y* Aspirin: 3.7%/y Apixaban: 1.4%/y Aspirin: 1.2%/y
ARISTOTLE26
Phase III		 Nonvalvular atrial fibrillation 5 mg BID Warfarin (INR 2-3) Median follow-up 1.8 y Stroke or systemic embolism Apixaban: 1.3%/y* Warfarin: 1.6%/y Apixaban: 2.1%/y* Warfarin: 3.1%/y
APPRAISE27
Phase II		 Secondary prevention after ACS 5Y20 mg/d Placebo 26 wk CV Death, MI, revascularization and Stroke 2.5 mg BID: 7.6% 10 mg/d: 6.0% Placebo: 8.7% 2.5 mg BID: 0.8% 10 mg/d: 0% 10 mg BID: 2.9%† 20 mg/d: 4.1%† Placebo: 0%
APPRAISE-228
Phase III		 Secondary prevention after ACS 5 mg BID Placebo Median follow-up 241 d CV Death, MI, and stroke Apixaban: 7.5% Placebo: 7.9% Major Bleeding Apixaban: 1.3%† Placebo: 0.5%
ADVANCE129
Phase III		 VTE prevention after TKR 2.5 mg BID Enoxaparin 30 mg BID 12 d VTE and all-cause mortality Apixaban: 9% Enoxaparin: 8.8% Apixaban: 0.7%* Enoxaparin: 1.4%
ADVANCE-230
Phase III		 VTE prevention after TKR 2.5 mg BID Enoxaparin 40 mg/d 12 d VTE and all-cause mortality Apixaban: 15%* Enoxaparin: 24% Apixaban: 0.6% Enoxaparin: 0.9%
ADVANCE-352
Phase III		 VTE prevention after THR 2.5 mg BID Enoxaparin 40 mg/d 35 d VTE and all-cause mortality Apixaban: 1.4%* Enoxaparin: 3.9% Apixaban: 0.8% Enoxaparin: 0.7%
Botticelli DVT53
Phase II		 Acute VTE treatment 5 mg or 10 mg BID, 20 mg/d Enoxaparin/warfarin 84Y91 d VTE and increased thrombotic burden: 5 mg BID: 6% 10 mg BID: 5.6% 20 mg/d: 2.6% Warfarin: 4.2% 5 mg BID: 0.7% 10 mg BID: 0% 20 mg/d: 1.6% Warfarin: 0%
Metastatic cancer54
Phase II		 VTE prevention metastatic cancer 5Y20 mg Placebo 12 wk Symptomatic VTE Apixaban: 0% Placebo: 10% 5 mg: 0% 10 mg: 0% 20 mg: 6% Placebo: 3%
*

Statistically significant superiority demonstrated over comparator.

†

Statistically significant inferiority demonstrated over comparator.

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