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: a Pragmatic, International, Multicentre, Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• Successful TAVI (according to the VARC-3 criteria)10 with any approved device

• Ability to understand and to comply with the study protocol

• Written informed consent

Locations
Other Locations
Netherlands
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Christiaan Overduin
c.overduin@antoniusziekenhuis.nl
+31883200931
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 2500
Treatments
Experimental: CT guided strategy
The intervention group will undergo CT scan after 3 months. If subclinical valve thrombosis is detected, anticoagulation will be started. If no subclinical valve thrombosis is detected, the SAPT is stopped, unless another indication is present.
No_intervention: Standard care
Standard of care with lifelong SAPT after TAVI
Sponsors
Collaborators: Pitié-Salpêtrière Hospital, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov

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