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

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05638100
Collaborator
(none)
300
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Rivaroxaban-H

    elderly patients (≥75-year-old) with NVAF administered Rivaroxaban(20mg/15mg)
    Rivaroxaban-M

    elderly patients (≥75-year-old) with NVAF administered Rivaroxaban(10mg)
    Rivaroxaban-L

    elderly patients (≥75-year-old) with NVAF administered Rivaroxaban(7.5mg)

    Outcome Measures

    Primary Outcome Measures

    1. incidence of stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack,myocardial infarction [January 2023-December 2025]

      collect the information of patients enrolled in this study suffered from stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack, myocardial infarction

    2. incidence of major bleeding, non-major clinically relevant bleeding, minor bleeding events [January 2023-December 2025]

      collect information of patients enrolled in this study suffered from major bleeding, non-major clinically relevant bleeding, minor bleeding events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    ClinicalTrials.gov Identifier:
    NCT05638100
    Other Study ID Numbers:
    • 2022-LCYJ-PY-32
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Dec 6, 2022