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Updated: Sep 15, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation
Jiawei Han1, Wenwei Qi1, Shuo Yuan1
1National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China; State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Background:
Non-vitamin K antagonist anticoagulant (NOAC) is considered the first-line treatment for atrial fibrillation (AF) patients to reduce the risk of stroke, especially in the elderly. However, robust clinical evidence is lacking regarding the appropriateness of low-dose NOAC.
Design:
The SAFE-AF trial is an investigator-initiated, multicenter, open-label, randomized controlled, blind endpoint evaluation, non-inferiority designed trial comparing the efficacy and safety of low-dose rivaroxaban with standard-dose rivaroxaban in patients aged ≥70 years with AF. Participants (N = 4,374) will be randomized 1:1 to receive either standard-dose rivaroxaban (20 mg once daily) or low-dose rivaroxaban (15 mg once daily). The primary efficacy endpoint is the composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolic events (SEE). The primary safety endpoint is the composite endpoint of major bleeding events and clinically relevant non-major bleeding events.
Conclusions:
The SAFE-AF trial is intended to provide valid evidence concerning low-dose rivaroxaban for anticoagulant therapy in older patients with AF.
Trial Registration:
ClinicalTrials.gov, identifier NCT06108414.
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