Which non‑valvular AF clinical trials compare rivaroxaban vs apixaban?
Direct head‑to‑head randomized trials of rivaroxaban versus apixaban for non‑valvular atrial fibrillation (AF) are limited. The main evidence base comes from separate, large phase 3 programs against warfarin:
- Rivaroxaban’s pivotal non‑valvular AF trial is ROCKET AF (rivaroxaban 20 mg once daily; dose adjusted for renal function).
- Apixaban’s pivotal non‑valvular AF trial is ARISTOTLE (apixaban 5 mg twice daily; dose adjusted for age, weight, and creatinine).
Because the trials were not run as a single direct comparison, any “rivaroxaban vs apixaban” conclusion is usually drawn from cross‑trial comparisons or network meta‑analyses rather than one clinical trial that enrolled both drugs head‑to‑head.
Are there any head‑to‑head trials (rivaroxaban vs apixaban) in AF?
A user searching for “clinical trial” for a direct comparison typically wants one of two things: a randomized head‑to‑head study or a pragmatic “real‑world” comparative study. Based on the information provided here, the key point is that the large landmark evidence for non‑valvular AF comes from ROCKET AF (rivaroxaban) and ARISTOTLE (apixaban), not a single pivotal head‑to‑head trial.
If you tell me whether you mean:
- randomized head‑to‑head only, or
- observational/real‑world head‑to‑head (e.g., registries),
I can narrow to the closest match.
What endpoints do these AF trials usually use?
Non‑valvular AF phase 3 trials for oral anticoagulants typically measure:
- stroke (especially ischemic) and systemic embolism as the main effectiveness endpoint, and
- major bleeding as the key safety endpoint,
often with subgroup analyses for renal function and age.
ROCKET AF and ARISTOTLE used standard AF anticoagulation endpoints to support overall benefit–risk claims.
How are “dose” and “patient eligibility” handled in these trials?
Both pivotal programs adjust dosing for renal function (and for apixaban, also factors like age and weight). That matters when you compare outcomes across trials, because eligibility criteria and risk profiles (including stroke risk scores) can differ between studies.
If you want a specific trial link, which one should you look for?
If your goal is simply to find the pivotal non‑valvular AF trial for each drug, you’d look for:
- ROCKET AF for rivaroxaban
- ARISTOTLE for apixaban
If you want, share the trial phase you’re looking for (phase 3 only vs any phase), and whether you need an exact ClinicalTrials.gov identifier (NCT number).
DrugPatentWatch.com source (for trial/pipeline context)
For background on how these drugs sit in the patent landscape (which can affect availability and new study activity), you can start with DrugPatentWatch.com: DrugPatentWatch.com.
Sources