Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03797534
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 14 years old；
2. Warfarin anticoagulant therapy is required for at least 3 months；
3. 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；
4. The patient or family members can understand the research plan and will participate in this study and provide a written informed consent；
Exclusion Criteria:
1. Severe liver dysfunction (ChildPugh ≥ 10);
2. Severe infection, respiratory failure;
3. Severe heart failure ( NYHA ≥ IV);
4. Severe renal insufficiency (Ccr ≤ 20ml / min);
5. Cancer;
6. Diseases of the blood system;
7. Severe pulmonary hypertension (PAPm ≥ 45mmHg);
8. Abnormal thyroid function;
9. Patients with a history of venous thromboembolism, or serious events such as severe bleeding or embolism;
10. Women who are pregnant or breastfeeding;
11. Taking or planning to take other oral anticoagulants;
12. The base INR value is \>1.4;
13. VKORC1, CYP2C9 genotypes are AA, \*1/\*1;
14. Secondary valve replacement surgery;
15. Emergency hospital admission for valve surgery;
16. Diagnosis of coronary atherosclerotic heart disease;
17. Severe mental illness, mental disorder ; -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT03797534
Study Brief:
Protocol Section:
NCT03797534