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Recruiting Phase 4 NCT06108414

Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation

Trial Parameters

Condition Atrial Fibrillation
Sponsor China National Center for Cardiovascular Diseases
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 4,374
Sex ALL
Min Age 70 Years
Max Age N/A
Start Date 2024-09-01
Completion 2026-12-31
Interventions
low-dose rivaroxabanStandard-dose rivaroxaban

Brief Summary

To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.

Eligibility Criteria

Inclusion criteria: * Age ≥70 years * Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 1 year) * CHA2DS2-VASc score ≥2 in men and ≥3 in women * Able to cooperate in signing ICFs Exclusion criteria: * Moderate-to-severe mitral stenosis, or prior mechanical valve replacement surgery, or unresected atrial myxoma, or known left ventricular thrombus * Prior biological valve replacement or valve repair surgery within 6 months * Left ventricular assist device implantation status * Severe stroke event within 3 months or any stroke within 14 days Major stroke events were defined as those with a Modified Rankin Scale score of 3-5. Score 3: moderately disabled, requiring some assistance but walking without assistance; Score 4: severe disability, unable to walk independently, unable to meet their own needs without the help of others; Score 5: severe disability, bedridden, incontinent, requiring ongoing care and attention

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