Clinical trial NCT06168370: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Aortic Valve Stenosis
Keywords: aortic stenosis
bleeding
tavi
ct
personalized antithrombotic therapy
tavr
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Pitié-Salpêtrière Hospital
First posted: 2023-12-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
* Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)
* Creatinine clearance \<15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy

Primary outcomes:
measure: Thromboembolic events
timeFrame: Through study completion, a median of 2.5 years
measure: All bleeding
timeFrame: Through study completion, a median of 2.5 years
Secondary outcomes:
measure: Net clinical benefit, defined as the composite of cardiovascular mortality, stroke, transient ischaemic attack, systemic embolism, clinically significant valve thrombosis and type 1-4 bleeding according to the VARC-3 criteria
timeFrame: Through study completion, a median of 2.5 years
measure: Major bleeding (VARC-3 type 2-4)
timeFrame: Through study completion, a median of 2.5 years
measure: Cerebrovascular events (All stroke and TIA according to VARC-3)
timeFrame: Through study completion, a median of 2.5 years
measure: Cardiovascular mortality
timeFrame: Through study completion, a median of 2.5 years
measure: All-cause mortality
timeFrame: Through study completion, a median of 2.5 years
measure: Aortic bio-prosthetic valve dysfunction assessed by echocardiography yearly after TAVI (standard care), as assessed according the VARC-3 criteria for Bioprosthetic Valve Dysfunction.
timeFrame: Through study completion, a median of 2.5 years
measure: Quality of life as assessed by EuroQol- 5 Dimension 5 Level (EQ-5D-5L) at baseline, 3 and 12 months, and then yearly after TAVI procedure.
timeFrame: Through study completion, a median of 2.5 years
measure: Quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and then yearly after TAVI procedure.
timeFrame: Through study completion, an median of 2.5 years
measure: Quality of life as assessed by Short Form Health Survey (SF-12) at baseline, 3 and 12 months, and then yearly after TAVI procedure.
timeFrame: Through study completion, a median of 2.5 years
measure: Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization.
timeFrame: Through study completion, a median of 2.5 years
measure: Cost-effectiveness assassment of a CT-guided antithrombotic strategy after TAVI using EQ-5D-5L
timeFrame: Through study completion, a median of 2.5 years
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
References: