Atrial FibrillationWADCHNCT01855737
The Study of Warfarin Maintenance Dose in Chinese Patients
An observational study of Atrial Fibrillation and Heart Valve Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
1. Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients 2. Drug: Warfarin 3. Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients. 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Valve Disease, Pulmonary Artery Embolism
- What is being tested?
- Warfarin
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Han population who need to use Warfarin and older than 18 years old.
Who may be able to join
- Chinese patients
- Age >18y
- target INR 1.5~3.0
- Patients signed informed consent
Who cannot join
- Has hemorrhage disease, or tendency to significant bleeding
- Severe liver and kidney disfunction, serious infections, severe heart failure (NYHA heart function classification Ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease
- patients with pregnancy or lactation;
- with cognitive impairment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
Yishi Li, MD, PhD, +86 10 88398395, lchyl_fuwai@sina.com
Yiling Huang, MS, +86 10 88398395, hyl0109@gmail.com
About this study
Official title: Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients
- Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
- Drug: Warfarin
- Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
- Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.
Read the detailed description
- For the patients who need to use warfarin, detect the "Vitamin K epoxide reductase complex subunit 1 (VKORC1),cytochrome p450 2C9 (CYP2C9), and cytochrome p450 4F2 (CYP4F2) genotype.
- Record the demographic information: gender, age, height, and weight.
- Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results.
- Put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.
- Being tested
- Warfarin
- Keywords
- gene guided, warfarin dose, Chinese
- Medical subject headings
- Atrial Fibrillation, Heart Valve Diseases, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Manufacturer: Orion Corporation, Product Name: Warfarin, 3mg*100
Prescribe warfarin to the patients who are needed.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin Using Group | Not described Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose
The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.
Measured: one month after the initial dose of warfarin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
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 Chinese Academy of Medical Sciences, Fuwai 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yishi Li, MD, PhD, Principal investigator, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeHong Liu, MS, Principal investigator, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855737
- Sponsor's protocol ID
- 2011-GZH1
- Acronym
- WADCH
- Status last verified
- Jun 2013
- First submitted
- 6 May 2013
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients
- ClinicalTrials.gov ID
- NCT01855737
- Acronym / sponsor ID
- WADCH / 2011-GZH1
- Keywords
- gene guided, warfarin dose, Chinese
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 16 May 2013 (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.
- Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
- Drug: Warfarin
- Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
- Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.
Detailed description
- For the patients who need to use warfarin, detect the "Vitamin K epoxide reductase complex subunit 1 (VKORC1),cytochrome p450 2C9 (CYP2C9), and cytochrome p450 4F2 (CYP4F2) genotype.
- Record the demographic information: gender, age, height, and weight.
- Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results.
- Put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warfarin Using Group | – | Drug: Warfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Han population who need to use Warfarin and older than 18 years old.
Key inclusion criteria (4 listed)
- Chinese patients
- Age >18y
- target INR 1.5~3.0
- Patients signed informed consent
Key exclusion criteria (4 listed)
- Has hemorrhage disease, or tendency to significant bleeding
- Severe liver and kidney disfunction, serious infections, severe heart failure (NYHA heart function classification Ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease
- patients with pregnancy or lactation;
- with cognitive impairment.
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 |
|---|---|---|
| WarfarinAlso: Manufacturer: Orion Corporation, Product Name: Warfarin, 3mg*100Prescribe warfarin to the patients who are needed. | Drug | Warfarin Using Group |
Primary outcome
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose
Time frame: one month after the initial dose of warfarin
The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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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.
Yishi Li, MD, PhD principal investigator
Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Hong Liu, MS principal investigator
Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Atrial Fibrillation and Heart Valve Disease, run by Chinese Academy of Medical Sciences, Fuwai 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 4 inclusion and 4 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 4 Jun 2013. 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 Hong Liu, MS (+86 10 88398547, winterliucn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose (time frame: one month after the initial dose of warfarin). 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 4 Jun 2013.