AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
Who is this study for? Patients aged >65 and <80 years old who underwent successful trans-catheter aortic valve implantation
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:
• Successful trans-catheter aortic valve implantation in patients aged \>65 and \<80 years old at the time of the procedure.
Locations
Other Locations
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Oslo University Hospital - Rikshospitalet
RECRUITING
Oslo
Oslo Univesity Hospital - Ullevål
NOT_YET_RECRUITING
Oslo
Contact Information
Primary
Øyvind H Lie, MD, PhD
oyvlie@gmail.com
+4793429011
Time Frame
Start Date: 2021-12-04
Estimated Completion Date: 2026-11
Participants
Target number of participants: 360
Treatments
Active_comparator: Acetylsalicylic acid
Patients in the active control arm will receive 75 mg acetylsalicylic acid once daily indefinitely.
Experimental: Direct oral anticoagulation (DOAC)
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Oslo
Leads: Oslo University Hospital