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
NCT ID: NCT06168370
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2500 participants
INTERVENTIONAL
2023-12-01
2028-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
CT guided strategy
1. With signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI are switched from SAPT to apixaban. Patients fulfilling the dose reduction criteria according to the drug label, or with a Clinical Frailty Scale ≥4 will receive 2.5mg bid, patients not meeting these criteria will receive a standard dose of 5mg bid.
2. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT.
3. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.
Standard care
Standard of care with lifelong SAPT after TAVI
No interventions assigned to this group
Interventions
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CT guided strategy
1. With signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI are switched from SAPT to apixaban. Patients fulfilling the dose reduction criteria according to the drug label, or with a Clinical Frailty Scale ≥4 will receive 2.5mg bid, patients not meeting these criteria will receive a standard dose of 5mg bid.
2. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT.
3. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and to comply with the study protocol
* Written informed consent
Exclusion Criteria
* 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
18 Years
110 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Pitié-Salpêtrière Hospital
OTHER
St. Antonius Hospital
OTHER
Responsible Party
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Jurriën M. ten Berg, MD, PhD
Clinical Professor
Locations
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St. Antonius Hospital
Nieuwegein, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jurrien ten berg, MD PhD
Role: primary
Other Identifiers
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2023-504637-42-01
Identifier Type: -
Identifier Source: org_study_id
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