Randomized, Evaluation of LoNg-term Anticoagulation with Oral Factor Xa Inhibitor versus Vitamin K Antagonist after Mechanical AorTic Valve ReplacEment

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0005315

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 1300

Inclusion Criteria

1. Aged = 19 years with successful mechanical aortic valve replacement
2. Mechanical heart valve in aortic valve position, for at least 3 months postoperatively
3. Good performance of prosthetic aortic valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak aortic valve velocity < 3 m/sec, no moderate or severe paravalvular/valvular regurgitation) according to VARC-2 criteria
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

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:
1)History of gastrointestinal ulcers or active ulcerations within the last 6 months
2)History of intracranial or intracerebral haemorrhage within the last 6 months
3)Spinal cord vascular abnormalities or intracerebral vascular abnormalities
4)History of the brain, spinal cord or ophthalmic surgery within the last 6 months
5)History of the brain or spinal cord injury within the last 6 months
6)oesophageal varices
7)Arteriovenous malformation
8)Vascular aneurysms
9)Malignant tumour with a high risk of bleeding
12.Bleeding tendencies associated with overt bleeding of;
ogastrointestinal, genitourinary or respiratory tract;
ocerebrovascular haemorrhage;
oaneurysms- cerebral, dissecting aorta;
opericarditis and pericardial effusions;
obacterial 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;
oSwitching anticoagulants
oIntravenous 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
oDiagnosed and documented ongoing anaemia or
oHemoglobin 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding(Bleeding Academic Research Consortium 3 or 5 Bleeding), and clinically-relevant non-major bleeding( Bleeding Academic Research Consortium 2 Bleeding)

Secondary Outcome Measures