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

ConditionsAORTIC VALVE DISEASESThromboembolism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorJoon Bum Kim

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 or regurgitation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rivaroxaban Oral Tablet

    Drug

    For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\_creatinine clearance 15-49 mL/min, 15mg once daily

  • Vitamin K antagonist(warfarin)

    Drug

    For 12months, keep the international normalized ratio (INR) 1.7-3.0

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: Oral Factor Xa inhibitorExperimental treatment 1 intervention
Group B: Vitamin K antagonistActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The event rate of the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding

A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. Clinically-relevant non-major bleeding is defined as BARC(Bleeding Academic Research Consortium) 2 Bleeding and major Bleeding is defined as BARC(Bleeding Academic Research Consortium) 3 or 5 Bleeding.

Time frame
1 year

Secondary outcomes

1

The event rate of all cause death

Time frame
1 year
2

The event rate of cardiovascular death

Time frame
1 year
3

The event rate of valve thrombosis confirmed by transthoracic echocardiography, transesophageal echocardiography, cine fluoroscopy, computed tomography, or autopsy (Valve Academic Research Consortium (VARC ) criteria)

Time frame
1 year
4

The event rate of valve-related thromboembolic event

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joon Bum Kim

Lead sponsor

Asan Medical Center

Sponsor institution

Source ClinicalTrials.gov
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