# Rivaroxaban

Drug · id `cardio:rivaroxaban` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Browse, condition area: Stroke; Heart rhythm problems  

## In plain language

The medicine inside Xarelto. It is a blood thinner taken by mouth. In the ROCKET AF trial it was compared with warfarin in people with non-valvular atrial fibrillation at increased risk of stroke. It was shown to be no worse than warfarin for stroke or a clot elsewhere in the body, was not shown to be better in the analysis of everyone randomized, and had a similar rate of major and clinically relevant bleeding.

## Technical summary

RxNorm ingredient 1114195. An oral factor Xa inhibitor (ROCKET AF abstract). Tested against warfarin in ROCKET AF (claim cardio:claim-rocket-af-rivaroxaban-vs-warfarin); brand name Xarelto in the US regulator's records (NDA 022406 for the original application and NDA 202439 for the atrial fibrillation indication). The numbers are on the claim.

## Claims, with the population each applies to

## Context: Adults with non-valvular atrial fibrillation at increased risk of stroke (ROCKET AF)

Recipient: Adult; Population: Patients with documented non-valvular atrial fibrillation on two separate occasions in the 6 months before screening, with a prior stroke, transient ischemic attack or systemic embolism, or at least two of: heart failure, hypertension, age 75 or older, diabetes (registry wording).; Care setting: Not stated in the abstract or the registry record; Geography: International (the registry lists sites in many countries; they are recorded on the study); Life stage: Adults aged 18 or older (registry minimum age); Follow-up: The registry gives an expected maximum treatment period of up to 32 months that may extend up to 4 years. The abstract gives no median follow-up.

### In ROCKET AF, a double-blind trial, 14,264 patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned to rivaroxaban at a daily dose of 20 mg or to dose-adjusted warfarin. The primary analysis was per-protocol and as-treated. In it, the primary end point, stroke or systemic embolism, occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio 0.79, 95% confidence interval 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 in the warfarin group (2.4% per year) (hazard ratio 0.88, 95% CI 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio 1.03, 95% CI 0.96 to 1.11; P=0.44). Intracranial hemorrhage (0.5% versus 0.7%, P=0.02) and fatal bleeding (0.2% versus 0.5%, P=0.003) were lower in the rivaroxaban group.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Adult; Population: Patients with documented non-valvular atrial fibrillation on two separate occasions in the 6 months before screening, with a prior stroke, transient ischemic attack or systemic embolism, or at least two of: heart failure, hypertension, age 75 or older, diabetes (registry wording).; Care setting: Not stated in the abstract or the registry record; Geography: International (the registry lists sites in many countries; they are recorded on the study); Life stage: Adults aged 18 or older (registry minimum age); Follow-up: The registry gives an expected maximum treatment period of up to 32 months that may extend up to 4 years. The abstract gives no median follow-up.
- Limitations: Abstract of the main report only. The primary analysis was per-protocol and as-treated. In the intention-to-treat analysis rivaroxaban was shown to be noninferior to warfarin but not superior (P=0.12). The paper and the registry give different participant counts: 14,264 patients in the abstract and 14269 in the registry, not reconciled here. The registry lists a 20 mg daily tablet with a dose adaptation to 15 mg for moderate renal impairment; the abstract gives the 20 mg daily dose only. The population was at increased risk of stroke. The abstract gives no median follow-up. The funding named in the abstract is Johnson & Johnson and Bayer.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, METHODS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Design and patient count (first fragment).
  2. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, METHODS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Dose and comparator (second fragment).
  3. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, METHODS, sentence 2, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Primary analysis type (first fragment).
  4. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, METHODS, sentence 2, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Primary end point (second fragment).
  5. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Primary analysis event counts (first fragment).
  6. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Primary analysis warfarin events and hazard ratio (second fragment).
  7. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 1, fragment 3. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Noninferiority P value (third fragment).
  8. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 2, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Intention-to-treat rivaroxaban events.
  9. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 2, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Intention-to-treat warfarin events and hazard ratio.
  10. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 2, fragment 3. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Intention-to-treat superiority P value.
  11. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 3, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Bleeding with rivaroxaban.
  12. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 3, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Bleeding with warfarin and hazard ratio.
  13. Supports: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, RESULTS, sentence 3, fragment 3. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Intracranial hemorrhage and fatal bleeding.
  14. Background: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: The authors' conclusion.
  15. Background: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, CONCLUSIONS, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: The authors' conclusion on bleeding.
  16. Background: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, CONCLUSIONS, sentence 3. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Funding and registry number.
  17. Background: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa1009638>
     Locator: Abstract, BACKGROUND, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Current. Snapshot hash: 67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14.
     How it applies: Rivaroxaban is an oral factor Xa inhibitor.
  18. Background: An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF) (Registry, edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2012-07-17.) <https://clinicaltrials.gov/study/NCT00403767>
     Locator: protocolSection.armsInterventionsModule.interventions\[0\].description. Retrieved 2026-10-14T18:18:36Z. Source state: Current. Snapshot hash: 4de7d66ff468389de8608c742b1a84ee2d1fae4ddabab4112251949157730158.
     How it applies: Registry dose adaptation for moderate renal impairment.
  19. Background: An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF) (Registry, edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2012-07-17.) <https://clinicaltrials.gov/study/NCT00403767>
     Locator: protocolSection.designModule.enrollmentInfo.count. Retrieved 2026-10-14T18:18:36Z. Source state: Current. Snapshot hash: 4de7d66ff468389de8608c742b1a84ee2d1fae4ddabab4112251949157730158.
     How it applies: Registry enrollment count, which differs from the abstract.

## Connected pages

- Compared with warfarin in ROCKET AF: Atrial fibrillation (AF) (`cardio:atrial-fibrillation`) [a claim, not a settled fact; see claim `cardio:claim-rocket-af-rivaroxaban-vs-warfarin` and its context]
- A direct oral anticoagulant used for this strategy: Blood thinners (oral anticoagulants) to prevent stroke in AF (`cardio:oral-anticoagulation`)
- Filed under this front: Medicines (`cardio:front-medicines`)
- Contained in: Rivaroxaban (Xarelto) (`cardio:xarelto`)
- Investigated in: ROCKET AF (`cardio:rocket-af`)

## Provenance

Content hash: 3718ab4be1e24796f8489adf7ae1be406ed0bd1a11ab779b580e4fa925397ba6
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14