The Study of Warfarin Maintenance Dose in Chinese Patients

NCT ID: NCT01855737

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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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. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.

Detailed Description

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* 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.

Conditions

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Atrial Fibrillation Heart Valve Disease Pulmonary Artery Embolism

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Warfarin Using Group

Warfarin

Intervention Type DRUG

Prescribe warfarin to the patients who are needed.

Interventions

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Warfarin

Prescribe warfarin to the patients who are needed.

Intervention Type DRUG

Other Intervention Names

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Manufacturer: Orion Corporation Product Name: Warfarin 3mg*100

Eligibility Criteria

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Inclusion Criteria

* Chinese patients
* Age \>18y
* target INR 1.5\~3.0
* Patients signed informed consent

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yishi Li, MD, PhD

Role: 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

Role: 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

Locations

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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, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Liu, MS

Role: CONTACT

+86 10 88398547

Yan Li, MD

Role: CONTACT

+86 10 88396298

Facility Contacts

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Yishi Li, MD, PhD

Role: primary

+86 10 88398395

Yiling Huang, MS

Role: backup

+86 10 88398395

Other Identifiers

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2011-GZH1

Identifier Type: -

Identifier Source: org_study_id

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