Aortic StenosisPhase 3ACASA-TAVINCT05035277
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
A Phase 3 study testing Acetylsalicylic acid, Apixaban and Rivaroxaban in people with Aortic Stenosis, run by Oslo University Hospital at 3 sites in Norway.
Trial summary
ACASA-TAVI is a pragmatic randomized controlled trial assessing the value of anticoagulation therapy versus the standard antiplatelet therapy after transcatheter aortic valve implantation in patients with aortic stenosis. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Acetylsalicylic acid, Apixaban and Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesNorway
- Study dates
- 4 Dec 2021to 5 Jun 2026
- Phase
- Phase 3
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Successful trans-catheter aortic valve implantation in patients aged >65 and <80 years old at the time of the procedure.
Who cannot join
- Strict indication for anticoagulation or anti-platelet drugs
- Strict contraindication for anticoagulation or anti-platelet drugs
- Overt cognitive failure
- Failure to obtain written informed consent
- Concomitant use of inducers or inhibitors of CYP3A4 or P-glycoprotein
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Haukeland University Hospital
Bergen, 5021
Oslo Univesity Hospital - Ullevål
Oslo, Oslo, 0424
Oslo University Hospital - Rikshospitalet
Oslo, 0772
About this study
ACASA-TAVI is a pragmatic randomized controlled trial assessing the value of anticoagulation therapy versus the standard antiplatelet therapy after transcatheter aortic valve implantation in patients with aortic stenosis. The trial will assess the efficacy of direct oral anticoagulation (DOAC) therapy compared to the standard single antiplatelet therapy to prevent degeneration of the valve and its safety in co-primary endpoints with blinded endpoint adjudication. The effect of DOAC therapy on hard clinical outcomes will be assessed during long-term follow-up.
Read the detailed description
Aortic stenosis is a highly prevalent valvular disease and an important cause of morbidity and mortality in the elderly population. Transcatheter aortic valve implantation (TAVI) is an effective intervention in patients with severe aortic stenosis and low surgical risk. The procedure is highly effective, safe, and widely implemented. Current recommendations support transcatheter treatment of younger patients, including patients from 65 years of age with low surgical risk. This practice increases the importance of long-term valve maintenance.
Observational data have suggested that early signs of valve degeneration (i.e. hypo-attenuated leaflet thickening/thrombosis/reduced leaflet motion) are associated with an increased risk of embolic events. This is an increasing problem with emerging indications in younger populations. Because both ischemic and bleeding complications after TAVI can be life-threatening, it is important to establish the optimal anti-thrombotic treatment regime. Use of oral anticoagulation after implantation for bioprosthetic valves have been associated with resolved valve degeneration and possible favourable clinical effects.
The current practice guidelines recommend that oral anticoagulation may be considered for 3 months after open surgical bioprosthetic valve implantation. Patients with an independent indication for oral anticoagulation (i.e. atrial fibrillation or venous thromboembolism) are recommended to continue this treatment lifelong, but there is no recommendation for oral anticoagulation following TAVI in patients without other indications. In patients without indication for oral anticoagulation, the use of double anti-platelet therapy for 3-6 months following TAVI is recommended. However, single anti-platelet therapy with acetylsalicylic acid (ASA) without clopidogrel has been reported to improve bleeding outcomes and a composite of bleeding and ischemic outcomes. The effect of on oral anticoagulation-based treatment strategy compared to the standard single anti-platelet treatment strategy for valve maintenance after TAVI is unknown.
Increased anti-thrombotic treatment intensity may come at the cost of increased bleeding risk. Dual anti-platelet therapy and combination therapy with anticoagulation and anti-platelet therapy have both been associated with unfavourable outcomes. Combined anti-platelet and anti-coagulation treatment has been shown to reduce valve degeneration at the cost of increased bleeding. Conversely, single anti-platelet therapy and anti-coagulation with a direct oral anti-coagulant (DOAC) have been associated with similar bleeding risk. Bleeding rates in patients treated with anti-coagulation after TAVI have been reported to be slightly higher than in patients treated with ASA after TAVI, but patients with conventional indications for anti-coagulation have higher baseline bleeding risk than those without such indications. Therefore, the risk of bleeding in patients treated with DOAC or ASA following TAVI may be similar, but no randomized trials have been performed.
ACASA-TAVI will include 360 patients > 65 years and < 80 years of age who have undergone successful TAVI and have no conventional indication for DOAC in a prospective randomized open-label blinded-endpoint (PROBE) study. The intervention arm will be 12 month therapy with an anti-Xa type DOAC (without antiplatelet therapy) and the active control arm will be standard dose ASA. After 12 months, the intervention group will be switched to ASA maintenance. All patients will undergo clinical assessment, cardiac CT and echocardiography at 12 months with blinded endpoint adjudication by an independent committee.
Outcome measures will comply with the Valve Academic Research Consortium 3 (VARC-3) consensus, and are described in detail in the protocol. The co-primary endpoints at 12 months, hypo-attenuated leaflet thickening (HALT) and safety composite, must both be met for the trial to declare success.
The effect of the DOAC therapy on long-term major adverse cardiovascular events (MACE) will be assessed after 5 years and 10 years.
- Conditions
- Aortic Stenosis
- Being tested
- Acetylsalicylic acid, Apixaban, Rivaroxaban, Edoxaban
- Keywords
- Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Antithrombotic therapy, Anticoagulation therapy, Antiplatelet therapy
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Also called B01A C06
Acetylsalicylic acid 75 mg once daily is the current standard-of-care in TAVI patients without other indications for anticoagulation therapy.
ApixabanDrug
Also called B01A F02
Standard dose apixaban will be one of the options for the patients in the experimental arm.
RivaroxabanDrug
Also called B01A F01
Standard dose rivaroxaban will be one of the options for the patients in the experimental arm.
EdoxabanDrug
Also called B01A F03
Standard dose edoxaban will be one of the options for the patients in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic acid | Active comparator | Patients in the active control arm will receive 75 mg acetylsalicylic acid once daily indefinitely. Receives: Drug: Acetylsalicylic acid |
| Direct oral anticoagulation (DOAC) | Experimental | Patients in the experimental arm will receive an anti Xa-type DOAC (apixaban, rivaroxaban or edoxaban) in approved therapeutic dose for 12 months. The choice of DOAC agent will be made by the treating clinician after discussion with the patient. After 12 months, these patients will abort DOAC therapy. Acetylsalicylic acid, 75 mg once daily will be started after DOAC discontinuation and continued indefinitely. Receives: Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypo-attenuated leaflet thickening
First co-primary endpoint. The presence of hypo-attenuated leaflet thickening on dedicated cardiac CT after 12 months will be registered by a blinded expert reader. Intention-to-treat, superiority.
Measured: 12 months
Safety composite - Incidence of Treatment Emergent Adverse Clinical Outcome
Second co-primary outcome. Composite of VARC-3 bleeding events, thromboembolic events (myocardial infarction or stroke) and all-cause mortality. Per-protocol, non-inferiority.
Measured: 12 months
Major adverse cardiovascular events (MACE)
Primary outcome during long-term follow-up. The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding.
Measured: 5 years
Major adverse cardiovascular events (MACE)
Primary outcome during long-term follow-up. The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding.
Measured: 10 years
Secondary outcomes (10)
Clinical efficacy
First hierarchical secondary outcome. Composite of of Freedom from all-cause mortality, Freedom from all stroke, Freedom from hospitalization for procedure- or valve-related causes, Freedom from KCCQ overall summary score <45 or decline from baseline of >10 points. Intention-to-treat, superiority.
Measured: 12 months
Safety composite, superiority
Second hierarchical secondary outcome. Composite of VARC-3 bleeding events, thromboembolic events (myocardial infarction or stroke) and all-cause mortality. Same endpoint as second co-primary outcome, but intention-to-treat, superiority.
Measured: 12 months
Thromboembolic events
Third hierarchical secondary outcome. Composite of myocardial infarction or stroke of any cause. Intention-to-treat population.
Measured: 12 months
Bleeding events
Fourth hierarchical secondary outcome. Bleeding events according to VARC-3 definitions. Intention-to-treat population.
Measured: 12 months
All-cause mortality
Fifth hierarchical secondary outcome. Intention-to-treat population.
Measured: 12 months
The number of adverse events
First secondary safety endpoint. Safety population.
Measured: 12 months
The number of serious adverse events
Second secondary safety endpoint. Safety population.
Measured: 12 months
Life-threatening or disabling bleeding
Third secondary safety endpoint. Safety population. VARC-3 definition.
Measured: 12 months
Major bleeding
Fourth secondary safety endpoint. Safety population. VARC-3 definition.
Measured: 12 months
Minor bleeding
Fifth secondary safety endpoint. Safety population. VARC-3 definition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start4 Dec 2021
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group prospective randomized open blinded endpoint (PROBE) trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Øyvind Lie, Oslo University Hospital
- Investigators
- Øyvind H Lie, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035277
- Sponsor's protocol ID
- 247400
- Other IDs
- 2021-001554-61
- Acronym
- ACASA-TAVI
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The application to share IPD is pending with the ethical committee.
Publications
VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
PubMed 33871579Dodgson CS, Herstad J, Klove SF, Flygel M, Akhavi M, Hoie S, Beitnes JO, Eek CH, Broch K, Cunen C, Gullestad L, Aaberge L, Lunde K, Bendz B, Lie OH. Anticoagulation Monotherapy vs Antiplatelet Monotherapy After Transcatheter Aortic Valve Implant: The ACASA-TAVI Randomized Clinical Trial. JAMA. 2026 Aug 30. doi: 10.1001/jama.2026.17036. Online ahead of print.
PubMed 42669043Dodgson CS, Beitnes JO, Klove SF, Herstad J, Opdahl A, Undseth R, Eek CH, Broch K, Gullestad L, Aaberge L, Lunde K, Bendz B, Lie OH. An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI. Am Heart J. 2023 Nov;265:225-232. doi: 10.1016/j.ahj.2023.08.010. Epub 2023 Aug 25.
PubMed 37634655
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05035277
- Acronym / sponsor ID
- ACASA-TAVI / 247400
- Conditions
- Aortic Stenosis
- Keywords
- Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Antithrombotic therapy, Anticoagulation therapy, Antiplatelet therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 5 Sep 2021 (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.
ACASA-TAVI is a pragmatic randomized controlled trial assessing the value of anticoagulation therapy versus the standard antiplatelet therapy after transcatheter aortic valve implantation in patients with aortic stenosis. The trial will assess the efficacy of direct oral anticoagulation (DOAC) therapy compared to the standard single antiplatelet therapy to prevent degeneration of the valve and its safety in co-primary endpoints with blinded endpoint adjudication. The effect of DOAC therapy on hard clinical outcomes will be assessed during long-term follow-up.
Detailed description
Aortic stenosis is a highly prevalent valvular disease and an important cause of morbidity and mortality in the elderly population. Transcatheter aortic valve implantation (TAVI) is an effective intervention in patients with severe aortic stenosis and low surgical risk. The procedure is highly effective, safe, and widely implemented. Current recommendations support transcatheter treatment of younger patients, including patients from 65 years of age with low surgical risk. This practice increases the importance of long-term valve maintenance.
Observational data have suggested that early signs of valve degeneration (i.e. hypo-attenuated leaflet thickening/thrombosis/reduced leaflet motion) are associated with an increased risk of embolic events. This is an increasing problem with emerging indications in younger populations. Because both ischemic and bleeding complications after TAVI can be life-threatening, it is important to establish the optimal anti-thrombotic treatment regime. Use of oral anticoagulation after implantation for bioprosthetic valves have been associated with resolved valve degeneration and possible favourable clinical effects.
The current practice guidelines recommend that oral anticoagulation may be considered for 3 months after open surgical bioprosthetic valve implantation. Patients with an independent indication for oral anticoagulation (i.e. atrial fibrillation or venous thromboembolism) are recommended to continue this treatment lifelong, but there is no recommendation for oral anticoagulation following TAVI in patients without other indications. In patients without indication for oral anticoagulation, the use of double anti-platelet therapy for 3-6 months following TAVI is recommended. However, single anti-platelet therapy with acetylsalicylic acid (ASA) without clopidogrel has been reported to improve bleeding outcomes and a composite of bleeding and ischemic outcomes. The effect of on oral anticoagulation-based treatment strategy compared to the standard single anti-platelet treatment strategy for valve maintenance after TAVI is unknown.
Increased anti-thrombotic treatment intensity may come at the cost of increased bleeding risk. Dual anti-platelet therapy and combination therapy with anticoagulation and anti-platelet therapy have both been associated with unfavourable outcomes. Combined anti-platelet and anti-coagulation treatment has been shown to reduce valve degeneration at the cost of increased bleeding. Conversely, single anti-platelet therapy and anti-coagulation with a direct oral anti-coagulant (DOAC) have been associated with similar bleeding risk. Bleeding rates in patients treated with anti-coagulation after TAVI have been reported to be slightly higher than in patients treated with ASA after TAVI, but patients with conventional indications for anti-coagulation have higher baseline bleeding risk than those without such indications. Therefore, the risk of bleeding in patients treated with DOAC or ASA following TAVI may be similar, but no randomized trials have been performed.
ACASA-TAVI will include 360 patients > 65 years and < 80 years of age who have undergone successful TAVI and have no conventional indication for DOAC in a prospective randomized open-label blinded-endpoint (PROBE) study. The intervention arm will be 12 month therapy with an anti-Xa type DOAC (without antiplatelet therapy) and the active control arm will be standard dose ASA. After 12 months, the intervention group will be switched to ASA maintenance. All patients will undergo clinical assessment, cardiac CT and echocardiography at 12 months with blinded endpoint adjudication by an independent committee.
Outcome measures will comply with the Valve Academic Research Consortium 3 (VARC-3) consensus, and are described in detail in the protocol. The co-primary endpoints at 12 months, hypo-attenuated leaflet thickening (HALT) and safety composite, must both be met for the trial to declare success.
The effect of the DOAC therapy on long-term major adverse cardiovascular events (MACE) will be assessed after 5 years and 10 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group prospective randomized open blinded endpoint (PROBE) trial
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic acid | Active comparator | Drug: Acetylsalicylic acidPatients in the active control arm will receive 75 mg acetylsalicylic acid once daily indefinitely. |
| Direct oral anticoagulation (DOAC) | Experimental | Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanPatients in the experimental arm will receive an anti Xa-type DOAC (apixaban, rivaroxaban or edoxaban) in approved therapeutic dose for 12 months. The choice of DOAC agent will be made by the treating clinician after discussion with the patient. After 12 months, these patients will abort DOAC therapy. Acetylsalicylic acid, 75 mg once daily will be started after DOAC discontinuation and continued indefinitely. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Successful trans-catheter aortic valve implantation in patients aged >65 and <80 years old at the time of the procedure.
Key exclusion criteria (5 listed)
- Strict indication for anticoagulation or anti-platelet drugs
- Strict contraindication for anticoagulation or anti-platelet drugs
- Overt cognitive failure
- Failure to obtain written informed consent
- Concomitant use of inducers or inhibitors of CYP3A4 or P-glycoprotein
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 |
|---|---|---|
| Acetylsalicylic acidAlso: B01A C06Acetylsalicylic acid 75 mg once daily is the current standard-of-care in TAVI patients without other indications for anticoagulation therapy. | Drug | Acetylsalicylic acid |
| ApixabanAlso: B01A F02Standard dose apixaban will be one of the options for the patients in the experimental arm. | Drug | Direct oral anticoagulation (DOAC) |
| RivaroxabanAlso: B01A F01Standard dose rivaroxaban will be one of the options for the patients in the experimental arm. | Drug | Direct oral anticoagulation (DOAC) |
| EdoxabanAlso: B01A F03Standard dose edoxaban will be one of the options for the patients in the experimental arm. | Drug | Direct oral anticoagulation (DOAC) |
Primary outcome
Hypo-attenuated leaflet thickening
Time frame: 12 months
First co-primary endpoint. The presence of hypo-attenuated leaflet thickening on dedicated cardiac CT after 12 months will be registered by a blinded expert reader. Intention-to-treat, superiority.
Safety composite - Incidence of Treatment Emergent Adverse Clinical Outcome
Time frame: 12 months
Second co-primary outcome. Composite of VARC-3 bleeding events, thromboembolic events (myocardial infarction or stroke) and all-cause mortality. Per-protocol, non-inferiority.
Major adverse cardiovascular events (MACE)
Time frame: 5 years
Primary outcome during long-term follow-up. The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding.
Major adverse cardiovascular events (MACE)
Time frame: 10 years
Primary outcome during long-term follow-up. The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding.
10 secondary outcomes
Clinical efficacy
Time frame: 12 months
Safety composite, superiority
Time frame: 12 months
Thromboembolic events
Time frame: 12 months
Bleeding events
Time frame: 12 months
All-cause mortality
Time frame: 12 months
The number of adverse events
Time frame: 12 months
The number of serious adverse events
Time frame: 12 months
Life-threatening or disabling bleeding
Time frame: 12 months
Major bleeding
Time frame: 12 months
Minor bleeding
Time frame: 12 months
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 9 Jun 2026.
- Background: PubMed 33871579VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
- Derived from this study: PubMed 42669043Dodgson CS, Herstad J, Klove SF, Flygel M, Akhavi M, Hoie S, Beitnes JO, Eek CH, Broch K, Cunen C, Gullestad L, Aaberge L, Lunde K, Bendz B, Lie OH. Anticoagulation Monotherapy vs Antiplatelet Monotherapy After Transcatheter Aortic Valve Implant: The ACASA-TAVI Randomized Clinical Trial. JAMA. 2026 Aug 30. doi: 10.1001/jama.2026.17036. Online ahead of print.
- Derived from this study: PubMed 37634655Dodgson CS, Beitnes JO, Klove SF, Herstad J, Opdahl A, Undseth R, Eek CH, Broch K, Gullestad L, Aaberge L, Lunde K, Bendz B, Lie OH. An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI. Am Heart J. 2023 Nov;265:225-232. doi: 10.1016/j.ahj.2023.08.010. Epub 2023 Aug 25.
- Individual participant dataSharing planned: Yes. The application to share IPD is pending with the ethical committee.
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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.
Øyvind H Lie, MD, PhD principal investigator
Oslo University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid, Apixaban and Rivaroxaban in people with Aortic Stenosis, run by Oslo University Hospital at 3 sites in Norway.
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 5 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Hypo-attenuated leaflet thickening (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035277, which also lists 3 linked publications.
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 9 Jun 2026.