Actively Recruiting

Phase 4
Age: 70Years +
All Genders
NCT06108414

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

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official 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 at least 30 seconds duration recorded by ECG or Holter within 1 year
  • CHA2DS2-VASc score of 2 or higher in men and 3 or higher in women
  • Able 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 within 3 months or any stroke within 14 days (Modified Rankin Scale score 3-5)
  • 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 catheter or surgical ablation over 3 months ago without atrial fibrillation ECG records
  • Planned or prior left atrial appendage occlusion
  • Active infective endocarditis
  • High or increasing risk for bleeding (recent traumatic surgery, severe hemorrhage, gastrointestinal bleeding, peptic ulcer, coagulopathy, difficult-controlled hypertension)
  • Severe renal impairment (creatinine clearance ≤ 15 mL/min)
  • Active liver disease including elevated liver enzymes, hepatitis, or cirrhosis
  • Hemoglobin below 100 g/L or low platelet count
  • Conditions requiring standard or low-dose anticoagulation for non-atrial fibrillation reasons
  • Conditions requiring warfarin therapy
  • Daily aspirin dose over 100 mg
  • Recent dual antiplatelet or intravenous antiplatelet therapy within 5 days
  • Recent or planned fibrinolysis treatment within 10 days
  • Use of certain interacting medications (CYP3A4 and P-gp inhibitors or inducers, SSRIs/SNRIs, long-term NSAIDs)
  • Allergic reactions to rivaroxaban components
  • Malignant tumors diagnosed within 6 months or receiving chemotherapy/radiotherapy with life expectancy under 3 years
  • Antiphospholipid syndrome
  • Participation in another interventional trial within 30 days
  • Mental disorders, cognitive impairment, or serious illnesses affecting study participation
  • Known poor adherence to follow-up or study drugs
  • Other conditions deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

Z

Zhe Zheng, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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