Warfarin Sodium Causing Adverse Effects in Therapeutic UseNCT06428110
A Prospective Cohort Study on Warfarin Personalized Medication
An observational study of Warfarin Sodium Causing Adverse Effects in Therapeutic Use, run by Haobin Li at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Warfarin Sodium Causing Adverse Effects in Therapeutic Use
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 12 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients taking warfarin
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200240
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Patients taking warfarin with vascular aging group | Not described | |
| Patients taking warfarin with normal vascular group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patients with bleeding events
Numbers of patients with bleeding events during warfarin treatment
Measured: 1 year during the follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jan 2021
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warfarin Sodium Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haobin Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haobin Li, Shanghai 5th People's Hospital
- Investigators
- Guangchun Sun, Principal investigator, The Fifth People's Hospital of Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428110
- Sponsor's protocol ID
- 2020081
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medication Research of Warfarin Based on Vascular Aging Assessment
- ClinicalTrials.gov ID
- NCT06428110
- Acronym / sponsor ID
- 2020081
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Haobin LiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients taking warfarin with vascular aging group | – | – |
| Patients taking warfarin with normal vascular group | – | – |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients taking warfarin
Key inclusion criteria (3 listed)
- Patients aged 65 years and older, taking warfarin, with or without premature vascular aging, regardless of gender.
Key exclusion criteria (6 listed)
- Patients who are allergic to warfarin or lactose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Patients taking warfarin with normal vascular group, Patients taking warfarin with vascular aging group |
Primary outcome
Numbers of patients with bleeding events
Time frame: 1 year during the follow-up
Numbers of patients with bleeding events during warfarin treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangchun Sun principal investigator
The Fifth People's Hospital of Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Warfarin Sodium Causing Adverse Effects in Therapeutic Use, run by Haobin Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of patients with bleeding events (time frame: 1 year during the follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.