A Prospective Cohort Study on Warfarin Personalized Medication

Personalized Medication Research of Warfarin Based on Vascular Aging Assessment

Analyze the impact of the degree of blood vessel aging on the anticoagulant effect and bleeding risk of warfarin. Evaluating the possibility of using the degree of blood vessel aging to guide individualized use of the anticoagulant drug warfarin.

Study Overview

• Status: Completed
• Conditions: Warfarin Sodium Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200240
      • The Fifth People's Hospital of Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients taking warfarin

Description

Inclusion Criteria:

• Patients aged 65 years and older, taking warfarin, with or without premature vascular aging, regardless of gender.

  • Patients who have not concurrently or intermittently used anticoagulant drugs, including antiplatelet drugs, heparin, low molecular weight heparin, and non-vitamin K-dependent oral anticoagulants, such as dabigatran and apixaban.

    • Signing an informed consent form before blood sample collection.

Exclusion Criteria:

• Patients who are allergic to warfarin or lactose.

  • Patients who are receiving immunosuppressive agents or low molecular weight heparin anticoagulants.

    • Patients with bleeding tendencies, blood disorders with platelet counts > 400 × 10^9 /L or < 100 × 10^9 /L, hemoglobin > 169 or < 100 g/L.

      • History of peptic ulcer disease.

        • Malignant tumors, severe multi-organ dysfunction or failure such as heart, liver, and kidney.

          • Neurological disorders such as epilepsy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients taking warfarin with vascular aging group
Patients taking warfarin with normal vascular group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of patients with bleeding events	Numbers of patients with bleeding events during warfarin treatment	1 year during the follow-up

Collaborators and Investigators

• Sponsor: Haobin Li
• Investigators: Principal Investigator: Guangchun Sun, The Fifth People's Hospital of Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No