Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joon Bum Kim
• Treatments: Apixaban; Factor Xa Inhibitors; Vitamin K; Vitamins; Warfarin

Criteria

Inclusion Criteria:

1. Age 19 and more

2. At least 3months after mechanical aortic valve replacement

3. At least one among the conditions(as defined below) is met

• The New York Heart Association (NYHA) Functional Classification I or II; or

• According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation

4. Voluntarily participated in the written agreement

Exclusion Criteria:

1. Old generation mechanical valve

2. History of mechanical valve implantation in the mitral valve, pulmonary valve or tricuspid valve

3. Valvular atrial fibrillation(atrial fibrillation with moderate-to-severe mitral stenosis)

4. History of hemorrhagic stroke

5. Clinically overt stroke within the last 3 months

6. Renal failure(creatinine clearance <15mL/min) or on hemodialysis

7. Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%

8. Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy

9. Clinically significant active bleeding

10. Bleeding or hemorrhagic disorder

11. The increased risk of bleeding due to the following reasons:

• History of gastrointestinal ulcers or active ulcerations within the last 6 months

• History of intracranial or intracerebral haemorrhage within the last 6 months

• Spinal cord vascular abnormalities or intracerebral vascular abnormalities

• History of the brain, spinal cord or ophthalmic surgery within the last 6 months

• History of the brain or spinal cord injury within the last 6 months

• oesophageal varices

• Arteriovenous malformation

• Vascular aneurysms

• Malignant tumour with a high risk of bleeding

12. Bleeding tendencies associated with overt bleeding of;

• gastrointestinal, genitourinary or respiratory tract;

• cerebrovascular haemorrhage;

• aneurysms- cerebral, dissecting aorta;

• pericarditis and pericardial effusions;

• bacterial endocarditis

13. Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy

14. Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted;

• Switching anticoagulants

• Intravenous UFH to keep central/arterial lines open

15. Uncontrolled moderate or severe hypertension

16. Gastrointestinal bleeding within 1year

17. Anaemia at least one among the conditions(as defined below) is met

• Diagnosed and documented ongoing anaemia or

• Hemoglobin level <10.0 g/dL or platelet count < 100 x 10 9/L within the last 6 months

18. Infective endocarditis

19. Hypersensitivity to the main component or constituents of Apixaban or Vitamin K antagonist

20. Positive pregnancy test results (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days prior to screening and/or randomization) or during pregnancy or lactation

21. Moderate to severe mitral stenosis

22. A genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

23. The unsuitable condition to the protocol

24. Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period

25. Terminal illness with life expectancy <12 months

26. Vitamin K deficiency

27. Alcoholic or psychical disorder

28. Threatened abortion, eclampsia or preeclampsia