CompletedPhase 3

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Norway360 participantsStarted 2021-12-04

Plain-language 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. 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.

Who can participate

Age range

65 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Successful trans-catheter aortic valve implantation in patients aged \>65 and \<80 years old at the time of the procedure. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared anticoagulation therapy to aspirin after a TAVR procedure — based on what they measured, like leaflet thickening and major cardiovascular events, has the data from this completed study changed what you would recommend for me after my own TAVR?
2The trial tracked something called hypo-attenuated leaflet thickening — can you explain what that means for the valve's long-term function, and whether my risk of developing it would influence your choice between anticoagulation and aspirin for me?
3Since this was a Phase 3 trial that has now completed, are the results published yet, and do they show any meaningful difference in safety or serious adverse events between the two medication approaches that I should factor into my decision?
4I know anticoagulants and aspirin carry different bleeding risks — based on what this trial measured in terms of safety outcomes, how would you weigh the bleeding risk against the potential cardiovascular benefit for someone in my specific situation?
5If the results of this trial favor one medication over the other after TAVR, how does that compare to what current standard guidelines already recommend, and would it change the treatment plan you'd normally suggest for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypo-attenuated leaflet thickening

Timeframe: 12 months

Safety composite - Incidence of Treatment Emergent Adverse Clinical Outcome

Timeframe: 12 months

Major adverse cardiovascular events (MACE)

Timeframe: 5 years

Major adverse cardiovascular events (MACE)

Timeframe: 10 years

Trial details

NCT IDNCT05035277

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-05

View on ClinicalTrials.gov More Aortic Stenosis trials