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

Phase 4

Not yet recruiting

• Conditions: Atrial Fibrillation; Anticoagulant Adverse Reaction; Major Adverse Cardiac Events; Stroke
• Interventions: Drug: Standard-dose rivaroxaban; Drug: low-dose rivaroxaban

• Registration Number: NCT06108414
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Start: 2024-08-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4374

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-dose rivaroxaban	Standard-dose rivaroxaban	20mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance \<50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the standard-dose group, the dose was reduced from the 20mg q.d. to 15mg q.d. .
Low-dose rivaroxaban	low-dose rivaroxaban	15mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance \<50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the low-dose group, the dose was reduced from the usual 15mg q.d. to 10mg q.d. .

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular and cerebrovascular events(MACCE)	Through study completion, an estimated average of 2 years	A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was firstly recorded after randomization

Secondary Outcome Measures

Name	Time	Method
Bleeding events	Through study completion, an estimated average of 2 years	A composite endpoint of ISTH major bleeding events and clinically relevant non major bleeding events was recorded after randomization
Net clinical benefit	Through study completion, an estimated average of 2 years	A composite endpoint of all-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, ISTH major bleeding events and clinically relevant non major bleeding events after randomization
Components of all primary and secondary outcome measures	Through study completion, an estimated average of 2 years	All-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, ISTH major bleeding events and clinically relevant non major bleeding events after randomization

Trial Locations

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, China