Rivaroxaban
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.
- Drug
- In this atlas
Overview
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 FDA records (NDA 022406 for the original application and NDA 202439 for the atrial fibrillation indication). The numbers are on the claim.
About this drug
- Level
- Substance
- Mechanism
- An oral factor Xa inhibitor (ROCKET AF abstract).
Claims and evidence
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.
Eligibility: 2 inclusion criteria; 6 exclusion criteria
- Included
- Documented atrial fibrillation on 2 separate occasions within 6 months before screening
- A prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of: heart failure, hypertension, age 75 or older, diabetes mellitus
- Excluded
- Significant mitral stenosis
- Transient atrial fibrillation caused by a reversible disorder
- Active internal bleeding
- Severe disabling stroke
- History of intracranial bleeding
- Hemorrhagic disorders
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.
Applies to Adult- 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).
- Not stated in the abstract or the registry record
- International (the registry lists sites in many countries; they are recorded on the study)
- Adults aged 18 or older (registry minimum age)
- Certainty method
- Not assessed
- 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
- Next evidence check due
- Not scheduled
Sources and citations (19)
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, METHODS, sentence 1, fragment 1
- How it applies
- Design and patient count (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, METHODS, sentence 1, fragment 2
- How it applies
- Dose and comparator (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, METHODS, sentence 2, fragment 1
- How it applies
- Primary analysis type (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, METHODS, sentence 2, fragment 2
- How it applies
- Primary end point (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 1
- How it applies
- Primary analysis event counts (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 2
- How it applies
- Primary analysis warfarin events and hazard ratio (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 3
- How it applies
- Noninferiority P value (third fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 2, fragment 1
- How it applies
- Intention-to-treat rivaroxaban events.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 2, fragment 2
- How it applies
- Intention-to-treat warfarin events and hazard ratio.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 2, fragment 3
- How it applies
- Intention-to-treat superiority P value.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 1
- How it applies
- Bleeding with rivaroxaban.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 2
- How it applies
- Bleeding with warfarin and hazard ratio.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 3
- How it applies
- Intracranial hemorrhage and fatal bleeding.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 1
- How it applies
- The authors' conclusion.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 2
- How it applies
- The authors' conclusion on bleeding.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 3
- How it applies
- Funding and registry number.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
- Locator
- Abstract, BACKGROUND, sentence 2
- How it applies
- Rivaroxaban is an oral factor Xa inhibitor.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21830957.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
- Locator
- protocolSection.armsInterventionsModule.interventions[0].description
- How it applies
- Registry dose adaptation for moderate renal impairment.
- Retrieved
- Source effective date
- 2012-07-17
- Source state
- Current
- Snapshot hash
4de7d66ff468389de8608c742b1a84ee2d1fae4ddabab4112251949157730158- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT00403767.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
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- Locator
- protocolSection.designModule.enrollmentInfo.count
- How it applies
- Registry enrollment count, which differs from the abstract.
- Retrieved
- Source effective date
- 2012-07-17
- Source state
- Current
- Snapshot hash
4de7d66ff468389de8608c742b1a84ee2d1fae4ddabab4112251949157730158- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT00403767.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
Clinical links
Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.
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Claim, not a settled fact Compared with warfarin in ROCKET AF: Atrial fibrillation (AF)
Applies to Adult- 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).
- Not stated in the abstract or the registry record
- International (the registry lists sites in many countries; they are recorded on the study)
- Adults aged 18 or older (registry minimum age)
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.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.
Record details
- Record id
cardio:rivaroxaban- Content hash
2271675972411e4673505fab82c75ea587ce874d06df16dabc1b2f35963d0425