Actively Recruiting

Phase 4
Age: 70Years +
All Genders
ID06108414

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

Led by China National Center for Cardiovascular Diseases · Updated on 2024-09-19

4374

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation. This Phase 4 randomized study focuses on patients aged 70 years and older who have atrial fibrillation and a CHA2DS2-VASc score indicating moderate to high stroke risk. The goal is to compare these dosing strategies to better understand their impact on cardiovascular and cerebrovascular events. Participants are randomly assigned to one of two groups: the low-dose group receives 15 mg of rivaroxaban daily, which may be reduced to 10 mg daily for certain conditions such as reduced kidney function, low body weight, or age 80 and above; the standard-dose group receives 20 mg daily, with dose reductions to 15 mg under the same conditions. Treatment lasts for approximately two years following randomization, with adherence to dosing guidelines based on individual health factors. During the study, participants will be monitored for major adverse cardiovascular and cerebrovascular events over about two years. Researchers will also track bleeding events, overall clinical benefits, and other related health outcomes. Assessments include regular clinical evaluations, safety monitoring, and follow-up visits to ensure patient well-being and gather data on the effects of both dosing regimens throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • Diagnosis of atrial fibrillation with rhythm lasting at least 30 seconds recorded by ECG or Holter within 1 year
  • CHA2DS2-VASc score of 2 or higher for men and 3 or higher for women
  • Ability to cooperate and sign informed consent forms
Not Eligible

You will not qualify if you...

  • Moderate-to-severe mitral stenosis, prior mechanical valve replacement, unresected atrial myxoma, or known left ventricular thrombus
  • Biological valve replacement or valve repair surgery within 6 months
  • Left ventricular assist device implantation
  • Severe stroke event within 3 months or any stroke within 14 days
  • Transient ischemic attack within 3 days
  • Transient atrial fibrillation due to reversible triggers
  • Planned or prior atrial fibrillation catheter ablation, drug cardioversion, electroconversion, or major surgery within 3 months
  • Prior or planned left atrial appendage occlusion
  • Active infective endocarditis
  • High or increasing bleeding risk including recent traumatic surgery, severe hemorrhages, gastrointestinal bleeding within past year, peptic ulcer within last month, bleeding disorders, or difficult-controlled hypertension
  • Severe renal impairment with creatinine clearance 15 mL/min or less
  • Active liver disease including persistent elevated liver enzymes, known hepatitis, or cirrhosis
  • Hemoglobin below 100g/L or low platelet count
  • Conditions requiring anticoagulation other than atrial fibrillation
  • Use of warfarin anticoagulation
  • Daily aspirin dose over 100mg
  • Recent dual antiplatelet or intravenous antiplatelet drug use within 5 days
  • Recent or planned fibrinolytic treatment
  • Use of certain interacting medications such as CYP3A4 and P-gp inhibitors, SSRIs, CYP3A4 inducers, or long-term NSAIDs
  • Allergic reactions to rivaroxaban ingredients
  • Recent malignant tumors or ongoing cancer treatment with limited life expectancy
  • Antiphospholipid syndrome
  • Participation in another clinical trial within past 30 days
  • Mental disorders or cognitive impairment affecting study participation
  • Known poor adherence to treatment or follow-up
  • Other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 years

Participants receive either low-dose or standard-dose rivaroxaban daily to reduce the risk of cardiovascular and cerebrovascular events.

Regular visits throughout the 2 years for treatment and monitoring

Trial Site Locations

Total: 1 location

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, 100037

Actively Recruiting

Loading map...

Research Team

Z

Zhe Zheng, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

320-detector Computed Tomography to Assess Myocardial Extrac...

Atrial Fibrillation

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF).

Jiawei Han, Wenwei Qi, Shuo Yuan...

https://pubmed.ncbi.nlm.nih.gov/40675206