A Prospective Cohort Study on Warfarin Personalized Medication

NCT06428110 | Completed DMC

• 1 other identifier: 2020081
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Warfarin Sodium Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• Numbers of patients with bleeding events

  Numbers of patients with bleeding events during warfarin treatment

  1 year during the follow-up

Study Arms (2)

Patients taking warfarin with vascular aging group

Patients taking warfarin with normal vascular group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients taking warfarin

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haobin Li: lead

Study Sites (1)

The Fifth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200240, China

Location

Study Officials

• Guangchun Sun

  The Fifth People's Hospital of Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: January 1, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)