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

NCT06108414 | Recruiting Phase 4

• 1 other identifier: NCRC2022002
• Study Type: interventional
• Target: 4,374
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebrovascular events(MACCE)

  A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was firstly recorded after randomization

  Through study completion, an estimated average of 2 years

Secondary Outcomes (3)

• Bleeding events

  Through study completion, an estimated average of 2 years

• Net clinical benefit

  Through study completion, an estimated average of 2 years

• Components of all primary and secondary outcome measures

  Through study completion, an estimated average of 2 years

Study Arms (2)

Low-dose rivaroxaban

EXPERIMENTAL

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. .

Drug: low-dose rivaroxaban

Standard-dose rivaroxaban

ACTIVE COMPARATOR

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. .

Drug: Standard-dose rivaroxaban

Interventions

low-dose rivaroxaban DRUG

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)

Low-dose rivaroxaban

Standard-dose rivaroxaban DRUG

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)

Standard-dose rivaroxaban

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years
• Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 1 year)
• CHA2DS2-VASc score ≥2 in men and ≥3 in women
• Able to cooperate in signing ICFs

You may not qualify if:

• Moderate-to-severe mitral stenosis, or prior mechanical valve replacement surgery, or unresected atrial myxoma, or known left ventricular thrombus
• Prior biological valve replacement or valve repair surgery within 6 months
• Left ventricular assist device implantation status
• Severe stroke event within 3 months or any stroke within 14 days Major stroke events were defined as those with a Modified Rankin Scale score of 3-5.
• Score 3: moderately disabled, requiring some assistance but walking without assistance; Score 4: severe disability, unable to walk independently, unable to meet their own needs without the help of others; Score 5: severe disability, bedridden, incontinent, requiring ongoing care and attention
• Transient ischemic attack (TIA) occurred within 3 days
• Transient atrial fibrillation due to reversible triggers (e.g., after cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
• Prior or planning to undergo atrial fibrillation catheter ablation, drug cardioversion, electroconversion, or major surgery in 3 months; Prior catheter or surgical ablation \> 3 months without atrial fibrillation electrocardiogram records
• Prior or planning to undergo left atrial appendage occlusion
• Active infective endocarditis
• High or increasing risk for bleeding i. Traumatic surgery that has been completed within the last 3 months or is planned within the next 3 months ii. Previous severe intracranial, intraocular, spinal cord, retroperitoneal, or nontraumatic intra-articular hemorrhage.
• iii. Gastrointestinal bleeding within the past year iv. Symptomatic or gastroscopic peptic ulcer within the last month v. Hemorrhagic constitution or coagulopathy vi. Difficult-controlled hypertension (180mm Hg systolic and/or 100 mm Hg diastolic)
• Severe renal impairment (estimated creatinine clearance ≤ 15 mL/min)
• Active liver disease
• Including but not limited to:

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (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, 100037, China

RECRUITING

Related Publications (1)

• Han J, Qi W, Yuan S, Liu H, Wang Y, Zhang H, Liu J, Zhao Y, Zhang Y, Zheng L, Yao Y, Zheng Z. 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). Am Heart J. 2025 Dec;290:268-277. doi: 10.1016/j.ahj.2025.07.011. Epub 2025 Jul 15.

  PMID: 40675206 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Cardiovascular Diseases

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Zhe Zheng, MD, PhD

CONTACT

+86 010 88396051; zhengzhe@fuwai.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)