AORTIC VALVE DISEASESPhase 4RENOVATENCT04258488
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
A Phase 4 study testing Rivaroxaban Oral Tablet and Vitamin K antagonist(warfarin) in people with AORTIC VALVE DISEASES and Thromboembolism, run by Joon Bum Kim at 16 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- AORTIC VALVE DISEASES, Thromboembolism
- What is being tested?
- Rivaroxaban Oral Tablet and Vitamin K antagonist(warfarin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 21 Feb 2022to 30 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 45Show fewer
- 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
- 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 before 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 of 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 the acute coronary syndrome
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
South Korea16 sites, 16 recruiting
- Recruiting
Buchen Sejong Hospital
Bucheon-si
Hee-moon Lee, MD
Hee-moon Lee, MD
- Recruiting
Dong-A University Hospital
Busan
Yong-rak Cho, MD
Yong-rak Cho, MD
- Recruiting
Keimyung University Dongsan Hospital
Daegu
Yoon-suk Kim, MD
Yoon-suk Kim, MD
- Recruiting
GangNeung Asan Hospital
Gangneung
Hanbit Park
Hanbit Park
- Recruiting
Chonnam National University Hospital
Gwangju
Kyo-sun Lee, MD
Kyo-sun Lee, MD
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Hyung Gon Je, MD
Hyung Gon Je
- Recruiting
Asan Medical Center
Seoul, 138-736
Joon-bum Kim, MD
Joon-bum Kim, MD
- Recruiting
Korea University Anam Hospital
Seoul
Ho-Sung Son, MD
Ho-Sung Son, MD
- Recruiting
Samsung Medical Center
Seoul
Dong-sub Jung, MD
Dong-sub Jung, MD
- Recruiting
Seoul National University Hospital
Seoul
Jae-woong Choi, MD
Jae-woong Choi, MD
- Not yet recruiting
Severance Hospital
Seoul
Gru Hong, MD
Gru Hong, MD
- Recruiting
Ajou University Hospital
Suwon
Soo Jin Park, MD
Soo Jin Park, MD
- Not yet recruiting
St. Vincent's Hospital, Catholic University of Korea
Suwon
Jin Won Shin, MD
Jin Won Shin, MD
- Recruiting
Eulji University Uijeongbu Hospital
Uijeongbu-si
Joon Lee
Joon Lee
- Not yet recruiting
Ulsan University Hospital
Ulsan
Kwan-sik Kim, MD
Kwan-sik Kim, MD
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
mi-hee Lim, MD
mi-hee Lim, MD
About this study
Official title: Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
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
- Being tested
- Rivaroxaban Oral Tablet, Vitamin K antagonist(warfarin)
- Keywords
- Aortic valve replacement, Mechanical valve
- Medical subject headings
- Aortic Valve Disease, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban Oral TabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Oral Factor Xa inhibitor | Experimental | Not described Receives: Drug: Rivaroxaban Oral Tablet |
| Vitamin K antagonist | Active comparator | Not described Receives: Drug: Vitamin K antagonist(warfarin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (19)
The event rate of all cause death
Measured: 1 year
The event rate of cardiovascular death
Measured: 1 year
The event rate of valve thrombosis confirmed by transthoracic echocardiography, transesophageal echocardiography, cine fluoroscopy, computed tomography, or autopsy (Valve Academic Research Consortium (VARC ) criteria)
Measured: 1 year
The event rate of valve-related thromboembolic event
Measured: 1 year
The event rate of transient ischemic attack
Measured: 1 year
The event rate of stroke
Measured: 1 year
The event rate of systemic embolism
Measured: 1 year
The event rate of myocardial infarction
Measured: 1 year
The event rate of major bleeding
BARC (Bleeding Academic Research Consortium) 3 or 5
Measured: 1 year
The event rate of Clinically-relevant non-major bleeding
BARC (Bleeding Academic Research Consortium) 2
Measured: 1 year
The event rate of the composite of cardiac death, valve thrombosis and valve-related thromboembolic event
Measured: 1 year
The event rate of the composite of cardiac death, valve thrombosis, stroke, systemic embolism and myocardial infarction event
Measured: 1 year
The event rate of the composite event of major bleeding and clinically-relevant non-major bleeding
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.
Measured: 1 year
The event rate of the composite of stroke, systemic embolism, transient ischemic attack and myocardial infarction event
Measured: 1 year
The event rate of the composite of all-cause death, stroke, systemic embolism, transient ischemic attack and myocardial infarction event
Measured: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : transaortic valve mean gradient
Measured: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : transaortic valve peak gradient
Measured: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : transaortic valve peak velocity
Measured: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : effective orifice area(EOA)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start21 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AORTIC VALVE DISEASESStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joon Bum Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joon Bum Kim, Asan Medical Center
- Investigators
- Jung-min Ahn, MD, Principal investigator, drjmahn@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258488
- Sponsor's protocol ID
- AMCCV2020-01
- Acronym
- RENOVATE
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04258488
- Acronym / sponsor ID
- RENOVATE / AMCCV2020-01
- Conditions
- AORTIC VALVE DISEASES, Thromboembolism
- Keywords
- Aortic valve replacement, Mechanical valve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Joon Bum KimUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Factor Xa inhibitor | Experimental | Drug: Rivaroxaban Oral Tablet |
| Vitamin K antagonist | Active comparator | Drug: Vitamin K antagonist(warfarin) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19 and more
- At least 3 months after mechanical aortic valve replacement
- At least one of the conditions(as defined below) is met
- Voluntarily participated in the written agreement
Key exclusion criteria (45 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban Oral TabletFor 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects_creatinine clearance 15-49 mL/min, 15mg once daily | Drug | Oral Factor Xa inhibitor |
| Vitamin K antagonist(warfarin)For 12months, keep the international normalized ratio (INR) 1.7-3.0 | Drug | Vitamin K antagonist |
Primary outcome
The event rate of the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding
Time frame: 1 year
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.
19 secondary outcomes
The event rate of all cause death
Time frame: 1 year
The event rate of cardiovascular death
Time frame: 1 year
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
The event rate of valve-related thromboembolic event
Time frame: 1 year
The event rate of transient ischemic attack
Time frame: 1 year
The event rate of stroke
Time frame: 1 year
The event rate of systemic embolism
Time frame: 1 year
The event rate of myocardial infarction
Time frame: 1 year
The event rate of major bleeding
Time frame: 1 year
The event rate of Clinically-relevant non-major bleeding
Time frame: 1 year
The event rate of the composite of cardiac death, valve thrombosis and valve-related thromboembolic event
Time frame: 1 year
The event rate of the composite of cardiac death, valve thrombosis, stroke, systemic embolism and myocardial infarction event
Time frame: 1 year
The event rate of the composite event of major bleeding and clinically-relevant non-major bleeding
Time frame: 1 year
The event rate of the composite of stroke, systemic embolism, transient ischemic attack and myocardial infarction event
Time frame: 1 year
The event rate of the composite of all-cause death, stroke, systemic embolism, transient ischemic attack and myocardial infarction event
Time frame: 1 year
The change of echocardiographic parameter
Time frame: 1 year
The change of echocardiographic parameter
Time frame: 1 year
The change of echocardiographic parameter
Time frame: 1 year
The change of echocardiographic parameter
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jung-min Ahn, MD principal investigator
drjmahn@gmail.com
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban Oral Tablet and Vitamin K antagonist(warfarin) in people with AORTIC VALVE DISEASES and Thromboembolism, run by Joon Bum Kim at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-hee Ham, RN (82230104728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The event rate of the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.