A Prospective Cohort Study on Warfarin Personalized Medication

Warfarin Sodium Causing Adverse Effects in Therapeutic Use Clinical Trial

Official title:

Personalized Medication Research of Warfarin Based on Vascular Aging Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06428110
• Other study ID #: 2020081
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 12, 2023

Study information

• Verified date: May 2024
• Source: Shanghai 5th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Warfarin Sodium Causing Adverse Effects in Therapeutic Use

Locations

Country	Name	City	State
China	The Fifth People's Hospital of Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Haobin Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of patients with bleeding events	Numbers of patients with bleeding events during warfarin treatment	1 year during the follow-up