RecruitingPhase 4NCT06108414

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

The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation


Sponsor

China National Center for Cardiovascular Diseases

Enrollment

4,374 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial compares a lower dose of rivaroxaban (a blood thinner) to the standard dose in older adults with atrial fibrillation, to see if a lower dose is just as effective but causes less bleeding. **You may be eligible if...** - You are 70 years or older - You have atrial fibrillation confirmed by ECG or Holter within the past year - Your stroke risk score (CHA2DS2-VASc) is high enough to require a blood thinner - You are able to sign an informed consent form **You may NOT be eligible if...** - You have moderate-to-severe mitral valve disease, a mechanical heart valve, or a left heart clot - You had a severe stroke recently (within 3 months) or any stroke in the past 14 days - Your atrial fibrillation is due to a temporary reversible cause (like after surgery) - You have plans for atrial fibrillation ablation or left atrial appendage closure in the next 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGlow-dose rivaroxaban

Rivaroxaban 15mg q.d. (The dose should be reduced to 10mg q.d. in the following special populations: 1. Creatinine clearance \<50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old)

DRUGStandard-dose rivaroxaban

Rivaroxaban 20mg q.d. (The dose should be reduced to 15mg q.d. in the following special populations: 1. Creatinine clearance \<50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old)


Locations(1)

National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT06108414


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