StrokeGWATNCT04482842
Gene-guided Warfarin for Anticoagulation Therapy
A study testing Gene detection (CYP2C9*3, VKORC1) and Warfarin Sodium in people with Stroke, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Gene detection (CYP2C9*3, VKORC1) and Warfarin Sodium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2020to 20 Aug 2021
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism patients)
- Clinicians judge that long-term oral anticoagulation with warfarin is required
- No anticoagulation treatment in the past 10 days
- Agree to participate in this project
Who cannot join
- Patients who had a tendency to bleed when taking warfarin
- High-risk groups using warfarin anticoagulation
About this study
Official title: Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke
This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.
- Conditions
- Stroke
- Being tested
- Gene detection (CYP2C9*3, VKORC1), Warfarin Sodium
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene detection (CYP2C9*3, VKORC1)Device
Warfarin is administered at the recommended dose by detecting CYP2C9*3 and VKORC1 gene polymorphismsand. The doctor adjusts the dosage according to the fluctuation of INR value in time.
Warfarin SodiumDrug
Warfarin is administered at a gene-guided dose or at a regular dose.
| Study group | Role | What they receive |
|---|---|---|
| Gene-guided Warfarin | Experimental | Not described Receives: Device: Gene detection (CYP2C9*3, VKORC1); Drug: Warfarin Sodium |
| Routine use | Other | Not described Receives: Drug: Warfarin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence rate, compliance rate of INR value
Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start10 Dec 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482842
- Sponsor's protocol ID
- XJTU1AF2020LSK-067
- Acronym
- GWAT
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04482842
- Acronym / sponsor ID
- GWAT / XJTU1AF2020LSK-067
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 23 Jul 2020 (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.
This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gene-guided Warfarin | Experimental | Device: Gene detection (CYP2C9*3, VKORC1), Drug: Warfarin Sodium |
| Routine use | Other | Drug: Warfarin Sodium |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism patients)
- Clinicians judge that long-term oral anticoagulation with warfarin is required
- No anticoagulation treatment in the past 10 days
- Agree to participate in this project
Key exclusion criteria (2 listed)
- Patients who had a tendency to bleed when taking warfarin
- High-risk groups using warfarin anticoagulation
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 |
|---|---|---|
| Gene detection (CYP2C9*3, VKORC1)Warfarin is administered at the recommended dose by detecting CYP2C9*3 and VKORC1 gene polymorphismsand. The doctor adjusts the dosage according to the fluctuation of INR value in time. | Device | Gene-guided Warfarin |
| Warfarin SodiumWarfarin is administered at a gene-guided dose or at a regular dose. | Drug | Gene-guided Warfarin, Routine use |
Primary outcome
Stroke recurrence rate, compliance rate of INR value
Time frame: 12 months
Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gene detection (CYP2C9*3, VKORC1) and Warfarin Sodium in people with Stroke, run by First Affiliated Hospital Xi'an Jiaotong University.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Stroke recurrence rate, compliance rate of INR value (time frame: 12 months). 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 25 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.