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NCT06168370: POP ATLANTIS

Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation

Recruiting now NA Last updated 25 April 2024
What this trial tests

NA trial testing CT guided strategy in Severe Aortic Valve Stenosis in 2,500 participants. Currently enrolling.

Timeline
1 December 2023
Primary endpoint
1 January 2028
1 June 2028

Quick facts

Lead sponsorSt. Antonius Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment2,500
Start date1 December 2023
Primary completion1 January 2028
Estimated completion1 June 2028
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

St. Antonius Hospital

Who can join

Adults 18 to 110, any sex, with Severe Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events. After 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antithrombotic therapy for transcatheter structural heart intervention.
    Guedeney P, Rodés-Cabau J, Ten Berg JM, Windecker S, et al · · 2024 · cited 6× · PMID 39155752 · DOI 10.4244/eij-d-23-01084
  2. Anti-Thrombotic Therapy Following Transcatheter Structural Heart Intervention.
    Tartaglia F, Antonelli G, Gabrielli A, Gitto M, et al · · 2026 · PMID 42074976 · DOI 10.3390/jcm15083175
  3. Thrombotic Versus Bleeding Risk After Transcatheter Aortic Valve Implantation
    Fotoula K, Ibrahem A, Harfoush A, Hussain H, et al · · 2026
  4. Optimal antithrombotic therapy after transcatheter aortic valve replacement: a comprehensive review.
    Thanh NVT, Hong MK, Ko YG. · · 2025 · PMID 40129765 · DOI 10.3389/fcvm.2025.1528071
  5. Antithrombotic Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
    Pallante F, Costa F, Garcia Ruiz V, Vizzari G, et al · · 2024

Verify or expand the search:

Other recruiting trials for Severe Aortic Valve Stenosis

Currently open trials in the same condition.

Other St. Antonius Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06168370.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing