Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06194617

Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

Led by Peking Union Medical College Hospital · Updated on 2024-01-08

300

Participants Needed

1

Research Sites

286 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with acute symptomatic pulmonary embolism diagnosed by imaging, with or without deep vein thrombosis, who have completed acute anticoagulation and entered maintenance phase
  • Life expectancy longer than 3 months
  • Meet indications for Xa factor inhibitor use
  • Willing to participate, sign informed consent, and attend regular follow-ups
Not Eligible

You will not qualify if you...

  • Moderate or severe liver impairment (Child-Pugh Class B or C)
  • Severe kidney impairment (creatinine clearance less than 15 mL/min)
  • Pregnant or breastfeeding women
  • Spontaneous bleeding tendencies such as coagulation disorders or low platelet count (less than 20 x 10^9/L)
  • Contraindications to Xa factor inhibitors
  • Diagnosed hereditary thrombophilia or antiphospholipid syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

J

juhong Shi, M.D

CONTACT

M

min Peng, M.D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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