Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
Study Details
Study Description
Brief Summary
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. . |
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)
|
| Active Comparator: 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. . |
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)
|
Outcome Measures
Primary Outcome Measures
- Major adverse cardiovascular and cerebrovascular events(MACCE) [At 24-month after randomization]
A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was recorded within 2 years after randomization
Secondary Outcome Measures
- Net clinical benefit [At 24-month after randomization]
All-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, and major bleeding events within 2 years after randomization
Eligibility Criteria
Criteria
Inclusion criteria:
-
Age ≥70 years
-
Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 6 months)
-
CHA2DS2-VASc score ≥2 in men and ≥3 in women
Exclusion criteria：
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Moderate-to-severe mitral stenosis or prior valve replacement surgery
-
Severe stroke event within 6 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
- 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.
- Gastrointestinal bleeding within the past year iv. Symptomatic or gastroscopic peptic ulcer within the last month v. Hemorrhagic constitution or coagulopathy vi. Use of fibrinolytic agents within 48 hours of enrollment vii. Difficult-controlled hypertension (180mm Hg systolic and/or 100 mm Hg diastolic) viii. Diagnosis of malignancy within 6 months or radiotherapy
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Transient atrial fibrillation due to reversible triggers (e.g., after cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
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Catheter ablation or surgery for AF is planned
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Severe renal impairment (estimated creatinine clearance ≤ 30 mL/min)
-
Active infective endocarditis
-
Active liver disease
Including but not limited to:
- Persistent ALT, AST, Alk Phos > 2×U; ii. Known active hepatitis C (HCV RNA positive);
- Active hepatitis B (HBs antigen +, anti-HBc IgM+); iv. Active hepatitis A
-
anemia (hemoglobin level <100g/L) or thrombocytopenia (thrombocytopenia count <100 × 10^9/L)
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patients enrolled in another study drug trial within the past 30 days or at the same time
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Patients whose condition warrants standard-dose anticoagulation
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Other conditions deemed by the investigator to be inappropriate for enrollment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCRC2022002