NCT06108414

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,374 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Atrial Fibrillation
• Anticoagulant Adverse Reaction
• Stroke
• Major Adverse Cardiac Events

Interventions

Type	Name	Description
DRUG	low-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)
DRUG	Standard-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)

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-10-31
• Last updated: 2024-09-19

Locations

1 site across 1 country: China