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

NCT04258488 | Recruiting Phase 4 DMC

• 1 other identifier: AMCCV2020-01
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

AORTIC VALVE DISEASES; Thromboembolism

Keywords

Aortic valve replacement; Mechanical valve

Outcome Measures

Primary Outcomes (1)

• Number of participants with 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.

  1 year

Secondary Outcomes (19)

• Number of Participants With all cause death

  1 year

• Number of Participants With cardiovascular death

  1 year

• Number of Participants With valve thrombosis confirmed by transthoracic echocardiography, transesophageal echocardiography, cine fluoroscopy, computed tomography, or autopsy (Valve Academic Research Consortium (VARC ) criteria)

  1 year

• Number of Participants With valve-related thromboembolic

  1 year

• Number of Participants With transient ischemic attack

  1 year

Study Arms (2)

Oral Factor Xa inhibitor

EXPERIMENTAL

Drug: Rivaroxaban Oral Tablet

Vitamin K antagonist

ACTIVE COMPARATOR

Drug: Vitamin K antagonist(warfarin)

Interventions

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

Oral Factor Xa inhibitor

Vitamin K antagonist(warfarin) DRUG

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

Vitamin K antagonist

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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%
• Child-Pugh B and C hepatic impairment or 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 hemorrhage within the last 6 months
• Spinal cord vascular abnormalities or intracerebral vascular abnormalities

Sponsors & Collaborators

• Joon Bum Kim: lead

Study Sites (15)

Buchen Sejong Hospital

Bucheon-si, South Korea

RECRUITING

Seoul National University Bundang Hospital

Bundang, South Korea

NOT YET RECRUITING

Dong-A University Hospital

Busan, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

RECRUITING

GangNeung Asan Hospital

Gangneung, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

St. Vincent's Hospital, Catholic University of Korea

Suwon, South Korea

NOT YET RECRUITING

Eulji University Uijeongbu Hospital

Uijeongbu-si, South Korea

NOT YET RECRUITING

Ulsan University Hospital

Ulsan, South Korea

NOT YET RECRUITING

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease; Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jung-min Ahn, MD

  drjmahn@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-hee Ham, RN

CONTACT

82230104728; cvcrc5@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: February 21, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

KR (15)