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CompletedNCT06428110Updated May 29, 2024

A Prospective Cohort Study on Warfarin Personalized Medication

An observational study in Warfarin Sodium Causing Adverse Effects in Therapeutic Use, sponsored by Haobin Li. Completed at 1 site in China. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Haobin Li · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
272
Ages
65 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Warfarin Sodium Causing Adverse Effects in Therapeutic Use
03

In context

Lead sponsor

This is the only study on the registry with Haobin Li as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients taking warfarin

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
272 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients taking warfarin with vascular aging group
  • Patients taking warfarin with normal vascular group
06

What researchers measure

Primary outcomes

  1. Numbers of patients with bleeding events

    Numbers of patients with bleeding events during warfarin treatment

    Time frame: 1 year during the follow-up

07

Study locations

1 site
  • The Fifth People's Hospital of Shanghai
    Shanghai, Shanghai 200240, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06428110
Lead sponsor
Haobin Li
Responsible party
Haobin Li (Principal Investigator, Shanghai 5th People's Hospital) — Sponsor-investigator
First posted
May 24, 2024
Start date
Jan 1, 2021
Primary completion
Dec 12, 2023
Completion
Dec 12, 2023
Last update
May 29, 2024

Study contacts

Guangchun Sun
principal investigator · The Fifth People's Hospital of Shanghai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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