Status:
UNKNOWN
Individualized Administration of Warfarin by Polymorphisms of VKORC1 and CYP2C9 Genes
Lead Sponsor:
Fujian Medical University
Conditions:
Heart Valve Prosthesis
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The purpose of this study is to explore the individualized administration model of warfarin suitable for Chinese people, and provide a scientific reference for the use of warfarin to Chinese people.
Detailed Description
About 600 patients with VKORC1 and CYP2C9 gene mutations were included in the treatment of warfarin anticoagulant therapy. The main indications include valve replacement, atrial fibrillation, pulmonar...
Eligibility Criteria
Inclusion
- Age \> 14 years old；
- Warfarin anticoagulant therapy is required for at least 3 months；
- The genotype of patient VKORC1 is non-AA, CYP2C9 genotype is non\*1/\*1； the patients who are followed up, regularly monitored for INR and willing to provide peripheral blood for DNA extraction and genetic testing；
- The patient or family members can understand the research plan and will participate in this study and provide a written informed consent；
Exclusion
- Severe liver dysfunction (ChildPugh ≥ 10);
- Severe infection, respiratory failure;
- Severe heart failure ( NYHA ≥ IV);
- Severe renal insufficiency (Ccr ≤ 20ml / min);
- Cancer;
- Diseases of the blood system;
- Severe pulmonary hypertension (PAPm ≥ 45mmHg);
- Abnormal thyroid function;
- Patients with a history of venous thromboembolism, or serious events such as severe bleeding or embolism;
- Women who are pregnant or breastfeeding;
- Taking or planning to take other oral anticoagulants;
- The base INR value is \>1.4;
- VKORC1, CYP2C9 genotypes are AA, \*1/\*1;
- Secondary valve replacement surgery;
- Emergency hospital admission for valve surgery;
- Diagnosis of coronary atherosclerotic heart disease;
- Severe mental illness, mental disorder ; -
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03797534
Start Date
February 1 2019
End Date
January 1 2023
Last Update
January 15 2019
Active Locations (1)
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1
the Department of Cardiovascular Surgery
Fuzhou, Fujian, China, 350001