Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
360
Countries
1
Sites
2
Aortic stenosis
To conduct a pragmatic randomized controlled trial assessing the optimal antithrombotic strategy in patients undergoing transcathter aortic valve implantation for aortic stenosis.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 7 Dec 2021 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Regional Health Trust of South-Eastern Norway
External identifiers
- EU CT number
- 2023-510211-20-00
- EudraCT number
- 2021-001554-61
- ClinicalTrials.gov
- NCT05035277
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Prophylaxis
To conduct a pragmatic randomized controlled trial assessing the optimal antithrombotic strategy in patients undergoing transcathter aortic valve implantation for aortic stenosis.
Conditions and MedDRA coding
Aortic stenosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10002906 | Aortic stenosis | 100000004866 |
| 20.0 | PT | 10002918 | Aortic valve stenosis | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age 65-80 years old
- Successful TAVI for aortic stenosis
- Signed informed consent form
- Expected compliance with protocol
Exclusion criteria 5
- Contraindications for any of the treatment arms
- Strict indication for antiplatelet drugs (i.e. percutaneous coronary intervention last 12 months, or other)
- Strict indication for oral anticoagulants (i.e. atrial fibrillation with high stroke risk, recent or recurrent venous thromboembolism, or other)
- Unable to start study medication within 72 hours after the procedure
- Drug interactions - Concomitant use of inhibitors of CYP3A4 and P-glycoprotein (such as the antimycotic agents ketoconazole, itraconazole, voriconazole, posaconazole and HIV-protease inhibitors) and inducers of CYP3A4 and P-glycoprotein (phenytoin, carbamazepine, phenobarbital or St. Johns wort).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Hypo-attenuated leaflet thickening, superiority
- Safety Composite, non-inferiority (bleeding, thromboembolic events and all-cause mortality)
Secondary endpoints 7
- Clinical efficacy, superiority (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)
- Safety Composite, superiority (bleeding, thromboembolic events and all-cause mortality)
- Thromboembolic events, superiority (Composite of myocardial infarction or stroke of any cause)
- Bleeding events, superiority (Bleeding events according to VARC-3 definitions)
- All-cause mortality, superiority
- Safety outcomes in safety population (adverse events, serious adverse events, individual bleeding outcomes)
- Long-term outcomes at 5 and 10 years (Major Adverse Cardiovascular Events/MACE: 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)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SUB29263 · Substance
- Active substance
- Rivaroxaban
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 7300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB29263 · Substance
- Active substance
- Rivaroxaban
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 5475 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32701 · Substance
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 10950 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32701 · Substance
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 21900 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25425 · Substance
- Active substance
- Apixaban
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25425 · Substance
- Active substance
- Apixaban
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 1825 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 27375 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Oslo universitetssykehus
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Oslo universitetssykehus
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 360 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2021-12-07 | 2021-12-07 | 2025-06-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 221110 ACASA-TAVI protocol v2-5 tracked | 1 |
| Protocol (for publication) | ACASA-TAVI protocol | 2.5 |
| Recruitment arrangements (for publication) | ACASA-TAVI informedconsent_patientrecruitmentprocedure_en | 1 |
| Recruitment arrangements (for publication) | ACASA-TAVI recruitment strategy | 1 |
| Subject information and informed consent form (for publication) | ACASA-TAVI informasjon og samtykke | 2.2 |
| Subject information and informed consent form (for publication) | ACASA-TAVI informedconsent_patientrecruitmentprocedure_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC apiksaban | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC ASA | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC edoksaban | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC rivaroksaban | 2.0 |
| Synopsis of the protocol (for publication) | ACASA-TAVI protocol synopsis | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Norway | Acceptable 2024-10-23
|
2024-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-06 | Norway | Acceptable 2025-06-23
|
2025-06-23 |