Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06194617
Status
Recruiting
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Conditions

  • Anticoagulant-induced Bleeding
  • Pulmonary Embolism
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Direct oral anticoagulant — DRUG
    Patients take DOACs according to their condition, with the dosage determined by the clinical physician.

Study Details

There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.

Key Dates

First listed
Jan 8, 2024
Start date
Apr 1, 2021
Status verified
Dec 2023
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients with pulmonary embolism and using direct oral anticoagulants
    Patients with pulmonary embolism and using direct oral anticoagulants

Primary Outcome Measure

Symptomatic recurrence of VTE. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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