Atrial FibrillationNCT03479684
Genotype-guided Versus Standard for Warfarin Dosing
A study testing Gene-directed dosage of warfarin and standard dosage of warfarin in people with Atrial Fibrillation and Valvular Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Valvular Heart Disease
- What is being tested?
- Gene-directed dosage of warfarin and standard dosage of warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 70 years old, requiring anticoagulation because of valvular or non-valvular atrial fibrillation or after valvular replacement. Patients could visit to be followed up in our hospital clinic regularly and agree to participate in the clinical trial and sign a written informed consent.
Who cannot join
- Patients will be excluded from the trial if aged <18 years old or > 75 years old, pregnant and lactating, if treated tricuspid valve replacement, or coronary artery bypass grafting before, if diagnosed with congenital heart disease, if known their CYP2C9 or VKORC1 genotype, if taken dicoumarol drugs previously or taking them now, if not suitable for enrollment judged by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences Fuwai Hospital
Beijing, Beijing Municipality, 100037
About this study
Official title: Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing
To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。
Read the detailed description
Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. Based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. Compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.
- Conditions
- Atrial Fibrillation, Valvular Heart Disease
- Being tested
- Gene-directed dosage of warfarin, standard dosage of warfarin
- Keywords
- warfarin, gene
- Medical subject headings
- Atrial Fibrillation, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene-directed dosage of warfarinOther
the first day given model prediction dose * 1.5 times（<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day
standard dosage of warfarinOther
the first day given 4.5mg; adjusted dose based on INR from the second day
| Study group | Role | What they receive |
|---|---|---|
| Gene-directed group | Experimental | the first day given model prediction dose * 1.5 times（<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day Receives: Other: Gene-directed dosage of warfarin |
| Standard care group | Active comparator | the first day given 4.5mg; adjusted dose based on INR from the second day Receives: Other: standard dosage of warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic INR range (TTR) 90
The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day90, and the TTR of all patients will be reported.
Measured: at Day90
Secondary outcomes (2)
therapeutic INR range (TTR) 28
The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day28, and the TTR of all patients will be reported.
Measured: at Day28
Time of the first time of the target INR
Time of the first time for participants to reach the target INR will be collected and reported during the study.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lu Hua, China National Center for Cardiovascular Diseases
- Investigators
- Lu Hua, MD. PhD, Principal investigator, Thrombosis and Vascular Medicine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479684
- Sponsor's protocol ID
- Z171100001017216
- Status last verified
- Apr 2022
- First submitted
- 27 Feb 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent for sharing of non identifiable study data for regulatory authorities.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing
- ClinicalTrials.gov ID
- NCT03479684
- Acronym / sponsor ID
- Z171100001017216
- Conditions
- Atrial Fibrillation, Valvular Heart Disease
- Keywords
- warfarin, gene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Mar 2018 (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.
To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。
Detailed description
Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. Based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. Compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gene-directed group | Experimental | Other: Gene-directed dosage of warfarinthe first day given model prediction dose * 1.5 times（<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day |
| Standard care group | Active comparator | Other: standard dosage of warfarinthe first day given 4.5mg; adjusted dose based on INR from the second day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged from 18 to 70 years old, requiring anticoagulation because of valvular or non-valvular atrial fibrillation or after valvular replacement. Patients could visit to be followed up in our hospital clinic regularly and agree to participate in the clinical trial and sign a written informed consent.
Key exclusion criteria (1 listed)
- Patients will be excluded from the trial if aged <18 years old or > 75 years old, pregnant and lactating, if treated tricuspid valve replacement, or coronary artery bypass grafting before, if diagnosed with congenital heart disease, if known their CYP2C9 or VKORC1 genotype, if taken dicoumarol drugs previously or taking them now, if not suitable for enrollment judged by researchers.
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-directed dosage of warfarinthe first day given model prediction dose * 1.5 times（<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day | Other | Gene-directed group |
| standard dosage of warfarinthe first day given 4.5mg; adjusted dose based on INR from the second day | Other | Standard care group |
Primary outcome
therapeutic INR range (TTR) 90
Time frame: at Day90
The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day90, and the TTR of all patients will be reported.
2 secondary outcomes
therapeutic INR range (TTR) 28
Time frame: at Day28
Time of the first time of the target INR
Time frame: 90 days
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 Apr 2022.
- Individual participant dataSharing planned: No. Consent for sharing of non identifiable study data for regulatory authorities.
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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.
Lu Hua, MD. PhD principal investigator
Thrombosis and Vascular Medicine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gene-directed dosage of warfarin and standard dosage of warfarin in people with Atrial Fibrillation and Valvular Heart Disease, run by China National Center for Cardiovascular Diseases 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 1 inclusion and 1 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 Apr 2022. 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?
therapeutic INR range (TTR) 90 (time frame: at Day90). 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 Apr 2022.