{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:rivaroxaban", "owner": "cardio", "kind": "drug", "slug": "rivaroxaban", "name": "Rivaroxaban", "aliases": [], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "1114195", "normalized_value": "1114195", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "condition-area": [ "arrhythmias", "stroke" ] } }, "payload": { "level": "substance", "mechanism": "An oral factor Xa inhibitor (ROCKET AF abstract)." }, "content_digest": "3718ab4be1e24796f8489adf7ae1be406ed0bd1a11ab779b580e4fa925397ba6", "review": { "content_digest": "3718ab4be1e24796f8489adf7ae1be406ed0bd1a11ab779b580e4fa925397ba6", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-rocket-af-rivaroxaban-vs-warfarin", "owner": "cardio", "subject_entity_id": "cardio:rivaroxaban", "category": "effect", "statement": "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.", "context": { "id": "cardio:ctx-rocket-af-nonvalvular-af-and-stroke-risk", "label": "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_note": "Adults aged 18 or older (registry minimum age)", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "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": { "inclusion": [ "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" ], "exclusion": [ "Significant mitral stenosis", "Transient atrial fibrillation caused by a reversible disorder", "Active internal bleeding", "Severe disabling stroke", "History of intracranial bleeding", "Hemorrhagic disorders" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 1, fragment 1", "applicability_note": "Design and patient count (first fragment).", "snapshot": { "id": "cardio:pubmed-21830957-2026-10-14", "retrieved_at": "2026-10-14T18:18:39Z", "content_hash": "67420596767ccfe0e2b559096cbec5bb7a9e3b95598e37e2d8b9d86950188c14", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:rocket-af-nejm-2011", "source_type": "publication", "title": "Rivaroxaban versus warfarin in nonvalvular atrial fibrillation", "canonical_url": "https://doi.org/10.1056/NEJMoa1009638", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1009638", "normalized_value": "10.1056/nejmoa1009638", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21830957", "normalized_value": "21830957", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-09-08", "publisher": "Journal record via PubMed (N Engl J Med 2011;365(10):883-91)", "edition": "PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. 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