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To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. . |
|
| 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. . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events | A composite endpoint of ISTH major bleeding events and clinically relevant non major bleeding events was recorded after randomization | Through study completion, an estimated average of 2 years |
| Net clinical benefit |
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Inclusion criteria:
Exclusion criteria:
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
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)
Including but not limited to:
i. Persistent ALT, AST > 2×ULN; ii. TBil > 1.5×ULN; iii. Known active hepatitis A, B or C; iv. Cirrhosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Zheng, MD, PhD | Contact | +86 010 88396051 | zhengzhe@fuwai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | Recruiting | Beijing | Beijing Municipality |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40675206 | Derived | 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. |
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| 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) |
|
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
| Through study completion, an estimated average of 2 years |
| Components of all primary and secondary outcome measures | All-cause death, myocardial infarction, stroke, transient ischemic attack, systemic embolism, ISTH major bleeding events and clinically relevant non major bleeding events after randomization | Through study completion, an estimated average of 2 years |
| 100037 |
| China |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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