Aortic Valve StenosisPhase 4NCT03807921
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
A Phase 4 study testing Warfarin and Aspirin in people with Aortic Valve Stenosis and Aortic Valve Disease, run by Instituto Nacional de Cirugia Cardiaca, Uruguay at 2 sites in Uruguay.
Trial summary
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency
- What is being tested?
- Warfarin and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUruguay
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication of aortic valve replacement with porcine bioprosthesis
Who cannot join
- Concomitant mitral valve replacement
- Previous atrial fibrillation
- Previous use oral anticoagulation
- Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy)
- Jehovah witness
- Platelet count below 90,000.
- Liver disease
Trial locations and contacts
2 sites in 1 country.
Uruguay2 sites
Centro Cardiovascular Universitario
Montevideo
Instituto Nacional de Cirugia Cardiaca
Montevideo
About this study
Official title: Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
Read the detailed description
Aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. Current guidelines support the use of aspirin (AAS) 100 mg as a class I indication.
Current evidence, mainly derived from transaortic valve implantation (TAVI) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. Anticoagulation in this cases improve leaflet mobility and decrease in gradient. Evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. Nonetheless, current American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend (IIa) the use of warfarin for at least 3 months after aortic valve replacement.
The aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. Comparison will be performed between the use of warfarin + aspirin vs aspirin alone. Duration of anticoagulation will be for 3 months and patients follow-up for 1 year. Clinical and echocardiographic evaluation will be performed in every patients. Some patients will undergo Positron Emission Tomography (PET-Scan).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Regurgitation
- Keywords
- aortic valve replacement, bioprosthesis, anticoagulation
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Experimental | Warfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months.
Aspirin will be administered 100 mg daily. Receives: Drug: Warfarin; Drug: Aspirin |
| Aspirin only | Active comparator | Aspirin will be started 48-72h after aortic valve replacement. Dose will be 100 mg daily. Patients who undergo coronary artery revascularization will receive 325 mg daily. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transprosthetic aortic gradient
Change in Transprosthetic mean gradient
Measured: 3 months and 1 year
Change in New York Heart Association (NYHA) class
NYHA class
Measured: 1 year
Secondary outcomes (3)
Major bleeding
number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion
Measured: 3 months and 1 year
Embolic events
Number of patients with cerebral and peripheral ischemic events
Measured: 3 months and 1 year
Prosthetic leak
Change in severity of prosthetic and paraprosthetic leakage
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cirugia Cardiaca, Uruguay
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Republica
- Responsible party
- Principal investigator, Victor Dayan, Instituto Nacional de Cirugia Cardiaca, Uruguay
- Investigators
- Victor Dayan, MD, PhD, Principal investigator, Instituto Nacional de Cirugia CardiacaDiego Freire, MD, Principal investigator, Centro Cardiovascular Universitario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807921
- Sponsor's protocol ID
- ANTIPRO
- Status last verified
- Feb 2022
- First submitted
- 15 Jan 2019
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
- ClinicalTrials.gov ID
- NCT03807921
- Acronym / sponsor ID
- ANTIPRO
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Regurgitation
- Keywords
- aortic valve replacement, bioprosthesis, anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Instituto Nacional de Cirugia Cardiaca, UruguayUniversity, hospital or other
- Collaborators
- Universidad de la Republica
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Jan 2019 (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 clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
Detailed description
Aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. Current guidelines support the use of aspirin (AAS) 100 mg as a class I indication.
Current evidence, mainly derived from transaortic valve implantation (TAVI) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. Anticoagulation in this cases improve leaflet mobility and decrease in gradient. Evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. Nonetheless, current American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend (IIa) the use of warfarin for at least 3 months after aortic valve replacement.
The aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. Comparison will be performed between the use of warfarin + aspirin vs aspirin alone. Duration of anticoagulation will be for 3 months and patients follow-up for 1 year. Clinical and echocardiographic evaluation will be performed in every patients. Some patients will undergo Positron Emission Tomography (PET-Scan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Experimental | Drug: Warfarin, Drug: AspirinWarfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months. Aspirin will be administered 100 mg daily. |
| Aspirin only | Active comparator | Drug: AspirinAspirin will be started 48-72h after aortic valve replacement. Dose will be 100 mg daily. Patients who undergo coronary artery revascularization will receive 325 mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication of aortic valve replacement with porcine bioprosthesis
Key exclusion criteria (7 listed)
- Concomitant mitral valve replacement
- Previous atrial fibrillation
- Previous use oral anticoagulation
- Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy)
- Jehovah witness
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 |
|---|---|---|
| WarfarinAlso: ChoiceOral anticoagulation | Drug | Warfarin |
| AspirinAlso: AASAntiplatelet treatment | Drug | Aspirin only, Warfarin |
Primary outcome
Transprosthetic aortic gradient
Time frame: 3 months and 1 year
Change in Transprosthetic mean gradient
Change in New York Heart Association (NYHA) class
Time frame: 1 year
NYHA class
3 secondary outcomes
Major bleeding
Time frame: 3 months and 1 year
Embolic events
Time frame: 3 months and 1 year
Prosthetic leak
Time frame: 3 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Yes. Study protocol.
Related trials for Aortic Valve Stenosis
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
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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. This study is not recruiting at the moment.
Victor Dayan, MD, PhD principal investigator
Instituto Nacional de Cirugia Cardiaca
Diego Freire, MD principal investigator
Centro Cardiovascular Universitario
2 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 Warfarin and Aspirin in people with Aortic Valve Stenosis and Aortic Valve Disease, run by Instituto Nacional de Cirugia Cardiaca, Uruguay at 2 sites in Uruguay.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uruguay. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transprosthetic aortic gradient (time frame: 3 months and 1 year). The study lists 2 primary outcomes in all. 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 8 Mar 2022.