Atrial Fibrillation Clinical Trial
— ESDDRECPNAFOfficial title:
Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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