post Heart Valve Prosthesis Surgery
Conditions
Interventions
control group:dosing per doctor's experience
experimental group A:genotype-based dosing
experimental group B:MAPB method (known genotype)
experimental group C:MAPB(unknown genotype)
Sponsors
Shanghai Chest Hospital, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. After valve replacement or valvuloplasty. 2. Require warfarin anticoagulation therapy for at least 6 months. 3. First use of warfarin. 4. Males or females aged >= 18 years. 5. Informed and agreed to sign an informed consent. 6. Ability and willingness to complete study visits as required by the programme.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding. 2. Subjects who have participated in other drug studies within the first 30 days or 5 half-lives of randomization (whichever is longer). 3. Life expectancy 85 years. 5. Severe end-stage organic diseases, such as. A, Chronic renal failure, eGFR = 10) C. Need for home oxygen therapy to maintain advanced lung disease. D, Cardiac function NYHA score IV. 6. Severe mental disorders, such as dementia. 7. Non-disabling ischemic stroke or previous severe disabling ischemic stroke in the 3 months prior to screening, or any history of intracranial hemorrhage. 8. History of alcohol or drug abuse. 9. Any disease or condition, past or present, judged by the investigator to be unsuitable for participation in the study. 10. Conditions with active bleeding or increased risk of bleeding, such as peptic ulcers, colitis or arteriovenous malformations of the brain, cerebral or aortic aneurysms, pericarditis or endocarditis. 11. Blood malignancy or hereditary haemostasis disorder. 12. Have a tendency to bleed or have had a severe bleeding event, such as bleeding from the skull, eyes, spinal cord or retroperitoneum. 13. History of hematuria or gastrointestinal bleeding. 14. With congenital or acquired diseases that require the use of anticoagulant inhibitors, which interfere with INR testing, such as. A, Antiphospholipid antibody syndrome or positive lupus anticoagulant. B, Prolonged prothrombin time due to endogenous inhibitors in the absence of anticoagulation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time in therapeutic range;excessive anticoagulant time ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time required to reach the treatment target INR for the first time;The time required from the beginning of treatment to the stable dose;counts of minor bleeding;counts of severe bleeding;counts of minor embolic events;counts of severe embolic events; | — |
Countries
China
Contacts
Public ContactBusheng Zhang
Shanghai Chest Hospital, Shanghai Jiao Tong University
Outcome results
None listed