Aortic Valve StenosisNOTION-4NCT06449469
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
A study testing Rivaroxaban, Acetylsalicylic acid and Clopidogrel in people with Aortic Valve Stenosis and Cardiovascular Diseases, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Rivaroxaban, Acetylsalicylic acid and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2021to 1 Apr 2030
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
- Residing in Denmark
- Provided written informed consent
Who cannot join
- Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
- Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding
- Patients with severe renal insufficiency (eGFR <30 mL/min/1.73 m2)
- Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI
- Iodine contrast allergy or other condition that prohibits CT imaging
- Age <18 years
- Women of childbearing potential, pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital, Skejby
Aarhus
Rigshospitalet
Copenhagen, 2100
About this study
Official title: Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves (NOTION-4)
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.
Read the detailed description
The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Valve Disease, Aortic
- Being tested
- Rivaroxaban, Acetylsalicylic acid, Clopidogrel, Edoxaban, Dabigatran
- Keywords
- heart valve disease, valvular bioprosthesis, aortic valve replacement, Randomized clinical trial, TAVI, Antitrombotic medication
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called SUB29263
Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines.
Acetylsalicylic acidDrug
Also called SUB12730MIG
Antiplatelets decrease platelet aggregation and inhibit thrombus formation. In NOTION-4 acetylsalicylic acid (75 mg once a day) is used as first line choice. For participants who are allergic to acetylsalicylic acid, clopidogrel (75 mg once a day) will be used. If the patient has already been prescribed Clopidogrel before the aortic valve intervention e.g. due to apoplexia, the patient will continue this medication following the procedure as an antiplatelet treatment, which is administered according to current guidelines.
ClopidogrelDrug
Also called SUB13395MIG
Antiplatelets decrease platelet aggregation and inhibit thrombus formation. In NOTION-4 acetylsalicylic acid (75 mg once a day) is used as first line choice. For participants who are allergic to acetylsalicylic acid, clopidogrel (75 mg once a day) will be used. If the patient has already been prescribed Clopidogrel before the aortic valve intervention e.g. due to apoplexia, the patient will continue this medication following the procedure as an antiplatelet treatment, which is administered according to current guidelines.
EdoxabanDrug
Also called SUB32701
Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines.
DabigatranDrug
Also called SUB20521
Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines.
ApixabanDrug
Also called SUB25425
Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines.
WarfarinDrug
Also called SUB05128MIG
If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Sinus rhythm - DOAC treatment | Experimental | Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin.
Duration: 3 months, followed by an anti-platelet hereafter. Receives: Drug: Rivaroxaban; Drug: Edoxaban; Drug: Dabigatran; Drug: Apixaban; Drug: Warfarin |
| Sinus rhythm - Anti-platelet treatment | Active comparator | Can be either of the following anti-platelet components: acetylsalicylic acid or clopidogrel.
Duration: Lifelong Receives: Drug: Acetylsalicylic acid; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
HALT after 1 year
The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.
Measured: At 1 year after TAVI
Secondary outcomes (14)
Combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding
Combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding
Measured: At 1 year and 5 years after TAVI
Incidence of patients with HALT during follow up
The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT.
Measured: At 3 months, 1 year and 5 years after TAVI
HALT on leaflets
Number of prosthetic leaflets with HALT at CT-scan.
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with ischemic stroke
The clinical endpoint of ischemic stroke verified by cerebrovascular imaging after the TAVI-procedure in patients with vs. without HALT.
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with stroke
Both ischemic and hemorrhagic strokes are included.
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with all-cause death
All cause mortality
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with cardiovascular mortality
Cardiovascular mortality as defined in current VARC definition
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with bleeding
Major bleeding or life-threatening bleeding
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with re-intervention
valve-in-valve TAVI, paravalvular leak closure, SAVR
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with aortic bioprosthetic dysfunction
According to EAPCI/ESC/EACTS definitions
Measured: At 3 months, 1 year and 5 years after TAVI
Number of participants with bioprosthetic valve failure
Rate of failure according to EAPCI/ESC/EACTS definitions including Rate of valve-related deaths, re-intervention, severe hemodynamic SVD
Measured: At 3 months, 1 year and 5 years after TAVI
NYHA classification
Assessing NYHA classification over time after TAVI
Measured: At 3 months, 1 year and 5 years after TAVI
Quality of life scores with 5-level EQ-5D version (EQ5D-5L)
Assessing changes of quality of life scores after TAVI with 5-level EQ-5D version (EQ5D-5L) where lower scores mean better outcome (score from 1 to 5).
Measured: At 3 months, 1 year and 5 years after TAVI
Quality of life scores with EQ Visual Analogue Scale (EQ VAS)
The EQ Visual Analogue Scale (EQ VAS) has minimum score 0 and maximum score 100, where higher scores mean better outcome.
Measured: At 3 months, 1 year and 5 years after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 May 2021
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Responsible party
- Principal investigator, Ole De Backer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ole De Backer, PhD, Principal investigator, Rigshospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449469
- Sponsor's protocol ID
- 2020-003361-19
- Other IDs
- 2020-003361-19
- Acronym
- NOTION-4
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jorgensen TH, Larsen AF, Jensen JM, Jensen RV, Willemen Y, Phoksiri A, Khokhar A, Thuraiaiyah J, Pedersen KB, Bieliauskas G, Terkelsen CJ, Sondergaard L, Kofoed KF, Norgaard BL, De Backer O; NOTION-4 Investigators. Short-Term Anticoagulant Therapy and Subclinical Leaflet Thickening in Transcatheter Aortic Valves: The NOTION-4 Trial. J Am Coll Cardiol. 2026 Aug 30:S0735-1097(26)07505-4. doi: 10.1016/j.jacc.2026.08.023. Online ahead of print.
PubMed 42669071Thuraiaiyah J, Jorgensen TH, Jensen JM, Fuchs A, Willemen Y, Terkelsen CJ, Kofoed KF, Sondergaard L, Norgaard BL, De Backer O. Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves-The NOTION-4 trial. Am Heart J. 2025 Jan;279:1-8. doi: 10.1016/j.ahj.2024.10.002. Epub 2024 Oct 5.
PubMed 39374638
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves (NOTION-4)
- ClinicalTrials.gov ID
- NCT06449469
- Acronym / sponsor ID
- NOTION-4 / 2020-003361-19
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Valve Disease, Aortic
- Keywords
- heart valve disease, valvular bioprosthesis, aortic valve replacement, Randomized clinical trial, TAVI, Antitrombotic medication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 10 Jun 2024 (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.
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.
Detailed description
The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus rhythm - DOAC treatment | Experimental | Drug: Rivaroxaban, Drug: Edoxaban, Drug: Dabigatran, Drug: Apixaban, Drug: WarfarinCan either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin. Duration: 3 months, followed by an anti-platelet hereafter. |
| Sinus rhythm - Anti-platelet treatment | Active comparator | Drug: Acetylsalicylic acid, Drug: ClopidogrelCan be either of the following anti-platelet components: acetylsalicylic acid or clopidogrel. Duration: Lifelong |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
- Residing in Denmark
- Provided written informed consent
Key exclusion criteria (7 listed)
- Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
- Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding
- Patients with severe renal insufficiency (eGFR <30 mL/min/1.73 m2)
- Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI
- Iodine contrast allergy or other condition that prohibits CT imaging
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 |
|---|---|---|
| RivaroxabanAlso: SUB29263Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - DOAC treatment |
| Acetylsalicylic acidAlso: SUB12730MIGAntiplatelets decrease platelet aggregation and inhibit thrombus formation. In NOTION-4 acetylsalicylic acid (75 mg once a day) is used as first line choice. For participants who are allergic to acetylsalicylic acid, clopidogrel (75 mg once a day) will be used. If the patient has already been prescribed Clopidogrel before the aortic valve intervention e.g. due to apoplexia, the patient will continue this medication following the procedure as an antiplatelet treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - Anti-platelet treatment |
| ClopidogrelAlso: SUB13395MIGAntiplatelets decrease platelet aggregation and inhibit thrombus formation. In NOTION-4 acetylsalicylic acid (75 mg once a day) is used as first line choice. For participants who are allergic to acetylsalicylic acid, clopidogrel (75 mg once a day) will be used. If the patient has already been prescribed Clopidogrel before the aortic valve intervention e.g. due to apoplexia, the patient will continue this medication following the procedure as an antiplatelet treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - Anti-platelet treatment |
| EdoxabanAlso: SUB32701Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - DOAC treatment |
| DabigatranAlso: SUB20521Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - DOAC treatment |
| ApixabanAlso: SUB25425Direct oral anticoagulants (DOAC) treatment will encompass any of the approved drugs: Rivaroxaban, Edoxaban, Dabigatranetexilat, and Apixaban (Table 1). The DOAC dosage will be adjusted according to kidney function (Table 1) and may be adjusted during the study period according to potential changes in guideline recommendations or if new-onset AF would occur in the follow-up period. The specific DOAC prescribed will be determined by the treating physician. If the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - DOAC treatment |
| WarfarinAlso: SUB05128MIGIf the patient has already been prescribed Marevan before the aortic valve intervention, the patient will continue this medication following the procedure as an oral anticoagulant treatment, which is administered according to current guidelines. | Drug | Sinus rhythm - DOAC treatment |
Primary outcome
HALT after 1 year
Time frame: At 1 year after TAVI
The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.
14 secondary outcomes
Combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding
Time frame: At 1 year and 5 years after TAVI
Incidence of patients with HALT during follow up
Time frame: At 3 months, 1 year and 5 years after TAVI
HALT on leaflets
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with ischemic stroke
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with stroke
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with all-cause death
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with cardiovascular mortality
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with bleeding
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with re-intervention
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with aortic bioprosthetic dysfunction
Time frame: At 3 months, 1 year and 5 years after TAVI
Number of participants with bioprosthetic valve failure
Time frame: At 3 months, 1 year and 5 years after TAVI
NYHA classification
Time frame: At 3 months, 1 year and 5 years after TAVI
Quality of life scores with 5-level EQ-5D version (EQ5D-5L)
Time frame: At 3 months, 1 year and 5 years after TAVI
Quality of life scores with EQ Visual Analogue Scale (EQ VAS)
Time frame: At 3 months, 1 year and 5 years after TAVI
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 Apr 2025.
- Derived from this study: PubMed 42669071Jorgensen TH, Larsen AF, Jensen JM, Jensen RV, Willemen Y, Phoksiri A, Khokhar A, Thuraiaiyah J, Pedersen KB, Bieliauskas G, Terkelsen CJ, Sondergaard L, Kofoed KF, Norgaard BL, De Backer O; NOTION-4 Investigators. Short-Term Anticoagulant Therapy and Subclinical Leaflet Thickening in Transcatheter Aortic Valves: The NOTION-4 Trial. J Am Coll Cardiol. 2026 Aug 30:S0735-1097(26)07505-4. doi: 10.1016/j.jacc.2026.08.023. Online ahead of print.
- Derived from this study: PubMed 39374638Thuraiaiyah J, Jorgensen TH, Jensen JM, Fuchs A, Willemen Y, Terkelsen CJ, Kofoed KF, Sondergaard L, Norgaard BL, De Backer O. Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves-The NOTION-4 trial. Am Heart J. 2025 Jan;279:1-8. doi: 10.1016/j.ahj.2024.10.002. Epub 2024 Oct 5.
- Individual participant dataSharing planned: No
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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.
Ole De Backer, PhD principal investigator
Rigshospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban, Acetylsalicylic acid and Clopidogrel in people with Aortic Valve Stenosis and Cardiovascular Diseases, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. 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 Denmark. 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.
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?
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?
HALT after 1 year (time frame: At 1 year after TAVI). 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 NCT06449469, which also lists 2 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 6 Apr 2025.