From the Guidelines
Rivaroxaban and apixaban both underwent the standard four phases of clinical trials required for FDA approval, including Phase I, II, III, and IV trials, as evident from the ROCKET AF and ARISTOTLE trials, respectively 1.
Phases of Clinical Trials
The clinical trials for rivaroxaban and apixaban were designed to evaluate their safety and efficacy in preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- Phase I trials established the safety profiles and pharmacokinetics of these medications in healthy volunteers.
- Phase II trials determined the optimal dosing regimens and preliminary efficacy in patients with various thrombotic conditions.
- Phase III trials, such as ROCKET AF for rivaroxaban and ARISTOTLE for apixaban, were large-scale randomized controlled trials that compared these medications to standard treatments, typically warfarin, for stroke prevention in atrial fibrillation, treatment of venous thromboembolism, and thromboprophylaxis after orthopedic surgery.
- Phase IV post-marketing surveillance studies continue to monitor the real-world safety and effectiveness of these medications.
Key Findings
The ROCKET AF trial, which compared rivaroxaban to warfarin, found that rivaroxaban was noninferior to warfarin in preventing stroke and systemic embolism, with a lower risk of intracranial hemorrhage and fatal bleeding 1. The ARISTOTLE trial, which compared apixaban to warfarin, found that apixaban was superior to warfarin in preventing stroke and systemic embolism, with a lower risk of major bleeding and death 1. These findings demonstrate that both rivaroxaban and apixaban offer predictable anticoagulation without routine monitoring requirements, with favorable risk-benefit profiles compared to vitamin K antagonists like warfarin 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Phases of Clinical Trials for Rivaroxaban and Apixaban
- The phases of clinical trials that Rivaroxaban (Xarelto) and Apixaban (Eliquis) underwent are not explicitly stated in the provided evidence, but it is mentioned that they have completed phase 3 clinical trials 2.
- Phase 3 clinical trials for these medications were conducted to compare their effectiveness and safety with other anticoagulants, such as warfarin, in patients with nonvalvular atrial fibrillation 3, 4, 5.
- The results of these phase 3 clinical trials showed that Rivaroxaban and Apixaban were effective in preventing stroke and systemic embolism, with a lower risk of intracranial bleeding compared to warfarin 3, 4, 5.
- Additional studies have been conducted to compare the efficacy and safety of Rivaroxaban, Apixaban, and Dabigatran in patients with atrial fibrillation, with results showing significant differences in outcomes between the three medications 6.
Key Findings from Clinical Trials
- Rivaroxaban and Apixaban have been shown to be effective in preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with a lower risk of intracranial bleeding compared to warfarin 3, 4, 5.
- The risk of bleeding associated with Rivaroxaban and Apixaban varies, with Rivaroxaban having a higher risk of bleeding compared to Apixaban 5.
- Head-to-head comparisons of Rivaroxaban, Apixaban, and Dabigatran have shown significant differences in outcomes, emphasizing the need for randomized controlled trials to guide the selection among these medications 6.