TABLE 3.
Phase II and III Clinical Trials Using Rivaroxaban
| Trial Name | Indication | Rivaroxaban Dose | Comparator | Treatment Duration | Thrombotic Outcome | Major Bleeding |
|---|---|---|---|---|---|---|
| ROCKET-AF12 Phase III |
Nonvalvular atrial fibrillation |
20 mg/d | Warfarin (INR 2Y3) |
Median treatment 19.7 mo |
Stroke and Systemic embolism Rivaroxaban: 2.12%/y‡ Warfarin: 2.42%/y |
Rivaroxaban: 3.6%/y Warfarin: 3.4%/y |
| ATLAS ACS-TIMI 4614 Phase II |
Secondary prevention after ACS |
5Y20 mg/d total dose |
Placebo | 6 mo | CV death, MI, stroke, revascularization 5 mg: 5.8% 10 mg: 3.8% 15 mg: 6.2% 20 mg: 5.5% Placebo: 5.1% |
5 mg: 0.7%† 10 mg: 1.5%† 15 mg: 1.8%† 20 mg: 1.8%† Placebo: 0.1% |
| ATLAS ACS-TIMI 5115 Phase III |
Secondary prevention after ACS |
2.5 mg and 5 mg BID |
Placebo | 31 mo | CV death, MI, stroke 2.5 mg BID: 9.1%* 5 mg BID: 8.8%* Placebo: 10.7% |
2.5 mg BID: 1.8%† 5 mg BID: 2.4%† Placebo: 0.6% |
| RECORD116 Phase III |
VTE prevention after THR |
10 mg/d | Enoxaparin 40 mg/d |
31 Y39 d | VTE and all-cause mortality Rivaroxaban: 1.1%* Enoxaparin: 3.7% |
Rivaroxaban: 0.3% Enoxaparin: 0.1% |
| RECORD217 Phase III |
VTE prevention after THR |
10 mg/d | Enoxaparin 40 mg/d |
31Y39 d, enoxaparin 10Y14 d |
VTE and all-cause mortality Rivaroxaban: 2%* Enoxaparin: 9.3% |
Rivaroxaban: G0.1% Enoxaparin: G0.1% |
| RECORD318 Phase III |
VTE prevention after TKR |
10 mg/d | Enoxaparin 40 mg/d |
10Y14 d | VTE and all-cause mortality Rivaroxaban: 9.6%* Enoxaparin: 18.9% |
Rivaroxaban: 0.6% Enoxaparin: 0.5% |
| RECORD419 Phase III |
VTE prevention after TKR |
10 mg/d | Enoxaparin 30 mg BID |
10Y14 d | VTE and all-cause mortality Rivaroxaban: 6.9%* Enoxaparin: 10.1% |
Rivaroxaban: 0.7% Enoxaparin: 0.3% |
| MAGELLAN50 Phase III |
VTE medical patients |
10 mg/d | Enoxaparin 40 mg daily |
35Y39 d, enoxaparin 10Y14 d |
VTE death and all VTE Rivaroxaban: 4.4%* Enoxaparin: 5.7% |
Rivaroxaban: 1.1%† Enoxaparin: 0.4% |
| ODIXa-DVT51 Phase II |
Acute VTE treatment |
10 mg, 20 mg, 30 mg BID or 40 mg/d |
Enoxaparin/warfarin (INR 2Y3) |
12 mo | Thrombotic burden and VTE death 10 mg BID: 53% 20 mg BID: 59.2% 30 mg BID: 56.9% 40 mg: 43.8% Warfarin: 45.9% |
10 mg BID: 1.7% 20 mg BID: 1.7% 30 mg BID: 3.3% 40 mg: 1.7% Warfarin: 0% |
| EINSTEIN21 Phase III |
Acute VTE treatment |
15 mg BID for 3 wk, 20 mg/d |
Enoxaparin/warfarin (INR 2Y3) |
3Y12 mo | Recurrent VTE Rivaroxaban: 2.1%‡ Warfarin: 3.0% |
Rivaroxaban: 0.8% Warfarin: 1.2% |
*
Statistically significant superiority demonstrated over comparator.
†
Statistically significant inferiority demonstrated over comparator.
‡
Statistically significant noninferiority demonstrated to comparator.
ACS, acute coronary syndrome; MI, myocardial infarction; THR, total hip replacement; TKR, total knee replacement.