Anticoagulation Treatment OverdoseSYSU-WARFANCT01633957
A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
A study testing Genotype-based Warfarin Initiation model and clinical factor-based warfarin initiation model in people with Anticoagulation Treatment Overdose and Heart Valve Diseases, run by Xi Zhang at 1 site in China.
Trial summary
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anticoagulation Treatment Overdose, Heart Valve Diseases
- What is being tested?
- Genotype-based Warfarin Initiation model and clinical factor-based warfarin initiation model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Aug 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
- willing to join in the clinical trial and comply with the protocol.
Who cannot join
- other ethnic groups than Han
- previously receive any other cardiac surgery
- emergent surgery
- simultaneously carry out other cardiac surgeries,such as CABG
- age younger than 18y or older than 65 year
- drug abuser and wine abuser
Show all 20Show fewer
- any malignancy
- moderate or severe hepatic or kidney insufficiency
- any thyroid disease
- the history of warfarin or VitK consumption 2 week before the surgery
- any hematological disease or history of bleeding
- combination with any drugs that significantly influence warfarin other than Cordarone
- pregnancy
- any contraindication of warfarin
- infectious endocarditis
- advanced valvular disease
- pathological obesity
- psychological disease
- any patient having joined in other clinical trial in the previous 30d
- basic INR > 1.4
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Sun Yat Sen University
Guangzhou, Guangdong, 510080
Xi Zhang, MD., 86-13902279690, zhangxisysu@163.com
Zhe Xu, MD.PHD., 86-13828453339, xuzhesums@163.com
About this study
Official title: Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.
Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.
- Being tested
- Genotype-based Warfarin Initiation model, clinical factor-based warfarin initiation model
- Keywords
- anticoagulation, bleeding, CYP2C9, CYP4F2, VKORC1, warfarin dosing, Heart Valve Diseases, pharmacogenomics
- Medical subject headings
- Heart Valve Diseases, Hemorrhage, Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotype-based Warfarin Initiation modelOther
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
clinical factor-based warfarin initiation modelOther
Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
| Study group | Role | What they receive |
|---|---|---|
| Genotype-based Warfarin Initiation | Experimental | Not described Receives: Other: Genotype-based Warfarin Initiation model |
| clinical factor-based warfarin initiation | Active comparator | Not described Receives: Other: clinical factor-based warfarin initiation model |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to steady dosage
Measured: from seven days after the operation to thirty days after the operation
Time in Therapeutic Range
Measured: from five days after the operation to thirty days after the operation
Secondary outcomes (8)
first time to treatment window
Measured: from five days after the operation to thirty days after the operation
the ratio of INR≥3.0 and INR≤1.5
Measured: from five days after the operation to thirty days after the operation
the monitoring frequency of INR
Measured: 30 days after the operation
the whole-cause mortality
Measured: 30 days after the operation
major bleeding event
Measured: 30 days after the operation
major thrombosis rate
Measured: 30 days after the operation
absolute difference between the stable dose and initial dose
Measured: 30 days after the operation
the frequency of dosage change
Measured: 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulation Treatment OverdoseStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Xi Zhang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xi Zhang, MD., Study director, First Affiliated Hospital, Sun Yat-Sen UniversityZhe Xu, MD.,PHD., Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633957
- Sponsor's protocol ID
- SYSU-XZ001
- Acronym
- SYSU-WARFA
- Status last verified
- Jul 2016
- First submitted
- 20 Jun 2012
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor
- ClinicalTrials.gov ID
- NCT01633957
- Acronym / sponsor ID
- SYSU-WARFA / SYSU-XZ001
- Keywords
- anticoagulation, bleeding, CYP2C9, CYP4F2, VKORC1, warfarin dosing, Heart Valve Diseases, pharmacogenomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xi ZhangUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 6 Jul 2012 (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.
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.
Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype-based Warfarin Initiation | Experimental | Other: Genotype-based Warfarin Initiation model |
| clinical factor-based warfarin initiation | Active comparator | Other: clinical factor-based warfarin initiation model |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
- willing to join in the clinical trial and comply with the protocol.
Key exclusion criteria (20 listed)
- other ethnic groups than Han
- previously receive any other cardiac surgery
- emergent surgery
- simultaneously carry out other cardiac surgeries,such as CABG
- age younger than 18y or older than 65 year
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 |
|---|---|---|
| Genotype-based Warfarin Initiation modelBased on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage. | Other | Genotype-based Warfarin Initiation |
| clinical factor-based warfarin initiation modelBased on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage. | Other | clinical factor-based warfarin initiation |
Primary outcome
time to steady dosage
Time frame: from seven days after the operation to thirty days after the operation
Time in Therapeutic Range
Time frame: from five days after the operation to thirty days after the operation
8 secondary outcomes
first time to treatment window
Time frame: from five days after the operation to thirty days after the operation
the ratio of INR≥3.0 and INR≤1.5
Time frame: from five days after the operation to thirty days after the operation
the monitoring frequency of INR
Time frame: 30 days after the operation
the whole-cause mortality
Time frame: 30 days after the operation
major bleeding event
Time frame: 30 days after the operation
major thrombosis rate
Time frame: 30 days after the operation
absolute difference between the stable dose and initial dose
Time frame: 30 days after the operation
the frequency of dosage change
Time frame: 30 days after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- one of the best warfarin dose modelLink provided by the sponsor.
Related trials for Anticoagulation Treatment Overdose
RecruitingObservational study
Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department
Hemorrhage, Thrombosis
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.
Xi Zhang, MD. study director
First Affiliated Hospital, Sun Yat-Sen University
Zhe Xu, MD.,PHD. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genotype-based Warfarin Initiation model and clinical factor-based warfarin initiation model in people with Anticoagulation Treatment Overdose and Heart Valve Diseases, run by Xi Zhang 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 2 inclusion and 20 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 25 Jul 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.
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 Xi Zhang, MD. (86-13902279690, zhangxisysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to steady dosage (time frame: from seven days after the operation to thirty days after the operation). The study lists 2 primary outcomes in all. 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 Jul 2016.