Heart Valve DiseasePhase 4POWATNCT02710747
The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
A Phase 4 study testing CYP2C9;VKORC1 in people with Heart Valve Disease and Older Than 18-years-old, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement. To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Valve Disease, Older Than 18-years-old, Without Any Liver or Kidney Diseases
- What is being tested?
- CYP2C9;VKORC1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jul 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- atrial fibrillation
- heart valve replacement
- VTE
Who cannot join
- severe liver or kidney diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Chen Yongbin, Master, +8618688859129, chenyb1020@hotmail.com
About this study
To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement.
To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
Read the detailed description
The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.
- Being tested
- CYP2C9;VKORC1
- Keywords
- warfarin, Chinese patients, heart valve replacement
- Medical subject headings
- Heart Valve Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C9;VKORC1Genetic
| Study group | Role | What they receive |
|---|---|---|
| Genetic Group | Experimental | Dose (mg/week) = [5.6044 - 0.02614 × Age [in years] + 0.0087 × Height [cm] + 0.0128 × Weight [kg] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 *1/*2 - 0.9357 × CYP2C9 *1/*3 - 1.0616 × CYP2C9 *2/*2 - 1.9206 × CYP2C9*2/*3 - 2.3312 × CYP2C9 *3/*3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2 Receives: Genetic: CYP2C9;VKORC1 |
| Control Group | No intervention | Dose for the first three days after operation will be 4.5mg/d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perccentage of time that the INR was in the therapeutic range
Measured: 3 months
Secondary outcomes (1)
all drainage fluid of every patient
Measured: 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710747
- Sponsor's protocol ID
- GDREC2014265H
- Acronym
- POWAT
- Status last verified
- Dec 2015
- First submitted
- 25 Feb 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
- ClinicalTrials.gov ID
- NCT02710747
- Acronym / sponsor ID
- POWAT / GDREC2014265H
- Keywords
- warfarin, Chinese patients, heart valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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 value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement.
To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
Detailed description
The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic Group | Experimental | Genetic: CYP2C9;VKORC1Dose (mg/week) = [5.6044 - 0.02614 × Age [in years] + 0.0087 × Height [cm] + 0.0128 × Weight [kg] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 *1/*2 - 0.9357 × CYP2C9 *1/*3 - 1.0616 × CYP2C9 *2/*2 - 1.9206 × CYP2C9*2/*3 - 2.3312 × CYP2C9 *3/*3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2 |
| Control Group | No intervention | –Dose for the first three days after operation will be 4.5mg/d. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- atrial fibrillation
- heart valve replacement
- VTE
Key exclusion criteria (1 listed)
- severe liver or kidney diseases
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 |
|---|---|---|
| CYP2C9;VKORC1 | Genetic | Genetic Group |
Primary outcome
The perccentage of time that the INR was in the therapeutic range
Time frame: 3 months
1 secondary outcome
all drainage fluid of every patient
Time frame: 1 week after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CYP2C9;VKORC1 in people with Heart Valve Disease and Older Than 18-years-old, run by Guangdong Provincial People's Hospital 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 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: status not confirmed, as of the sponsor's last update on 17 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Yongbin, master (+8618688859129, chenyb1020@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perccentage of time that the INR was in the therapeutic range (time frame: 3 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 17 Mar 2016.