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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1300
  • sponsor
    Joon Bum Kim
Updated on 9 August 2022
regurgitation
warfarin
rivaroxaban
factor xa inhibitor

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.

Details
Condition AORTIC VALVE DISEASES, Thromboembolism
Treatment Rivaroxaban Oral Tablet, Vitamin K antagonist(warfarin)
Clinical Study IdentifierNCT04258488
SponsorJoon Bum Kim
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 19 and more
At least 3 months after mechanical aortic valve replacement
At least one of 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
Voluntarily participated in the written agreement

Exclusion Criteria

Old generation mechanical valve
History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve
Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis)
Moderate to severe mitral stenosis
History of hemorrhagic stroke
Clinically overt stroke within the last 3 months
Renal failure(creatinine clearance <15mL/min) or on hemodialysis
Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%
Hepatic impairment, or severe (Child-Pugh C) or with any hepatic disease associated with coagulopathy
Clinically significant active bleeding
Bleeding or hemorrhagic disorder
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
History of the brain or spinal cord injury or spinal tap, major regional anesthesia or, spinal anesthesia within the last 6 months
Esophageal varices
Arteriovenous malformation
Vascular aneurysms
Malignant tumor with a high risk of bleeding
Bleeding tendencies associated with overt bleeding of
gastrointestinal, genitourinary, respiratory tract or, colorectal cancer
cerebrovascular hemorrhage
aneurysms- cerebral, dissecting aorta
pericarditis and pericardial effusions
bacterial endocarditis
Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy
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
Uncontrolled moderate or severe hypertension
Anemia at least one among the conditions(as defined below) is met 1) Hemoglobin level <10.0 g/dL or platelet count < 100 x 10x9/L within the last 6 months 2) Diagnosed and documented ongoing anemia
Infective endocarditis
Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist
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
A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
The unsuitable condition to the protocol
Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period
Terminal illness with life expectancy <12 months
Vitamin K deficiency
Alcoholic or psychical disorder
Threatened abortion, eclampsia, or preeclampsia
Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of acute coronary syndrome
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