Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation

Study Overview
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Brief Summary
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From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up.

Detailed Description
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To explore the appropriate dose of rivaroxaban to prevent stroke in elderly Chinese patients with nonvalvular atrial fibrillation in order to improve the effectiveness and safety of anticoagulation therapy. From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up. The efficacy indexes include stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack and myocardial infarction, and the safety indexes include major bleeding, non-major clinically relevant bleeding, minor bleeding events.

Official Title
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Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥75 years Chinese patient: male or female Patients had to be diagnosed as nonvalvular atrial fibrillation (NVAF) Exclusion Criteria: Patients with anemia (hemoglobin<100g/L), known human immunodeficiency virus infection, female patients who were pregnant or lactating and patients for whom warfarin was contraindicated, were also excluded Patients with calculated creatine clearance vulue<30ml/min Patients expected to chronically use a non-steroidal anti-inflammatory agent (except for external preparations) and those treated with a strong cytochrome P4503A4 inhibitor (eg, ketoconazole, clarithromycin, or protease inhibitors) or a strong cytochrome P450 3A4 inducer (eg, rifampicin) during the trial

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban-H<br>elderly patients (≥75-year-old) with NVAF administered Rivaroxaban(20mg/15mg) | |
| Rivaroxaban-M<br>elderly patients (≥75-year-old) with NVAF administered Rivaroxaban(10mg) | |
| Rivaroxaban-L<br>elderly patients (≥75-year-old) with NVAF administered Rivaroxaban(7.5mg) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack,myocardial infarction | collect the information of patients enrolled in this study suffered from stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack, myocardial infarction | January 2023-December 2025 | 
| incidence of major bleeding, non-major clinically relevant bleeding, minor bleeding events | collect information of patients enrolled in this study suffered from major bleeding, non-major clinically relevant bleeding, minor bleeding events | January 2023-December 2025 |