Personalized antithrombotic therapy for patients after aortic valve replacement
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
This study is testing if a personalized blood-thinning treatment can help people who have had aortic valve replacement feel better and avoid complications compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 1 site (Nieuwegein) |
| Trial ID | NCT06168370 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of CT-guided antithrombotic therapy compared to standard lifelong single antiplatelet therapy in patients who have undergone transcatheter aortic valve implantation (TAVI) and do not require anticoagulants. The study aims to assess the presence of thrombosis on the newly implanted valve using a 4D CT scan three months post-procedure. Based on the scan results, patients may receive tailored antithrombotic therapy with apixaban, potentially reducing thromboembolic events while minimizing bleeding risks. This approach seeks to improve patient outcomes following TAVI.
Who should consider this trial
Good fit: Ideal candidates are patients who have successfully undergone TAVI and do not have indications for anticoagulant or dual antiplatelet therapy.
Not a fit: Patients with existing indications for anticoagulation or dual antiplatelet therapy, as well as those with severely impaired renal function, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of thromboembolic risks without increasing the likelihood of bleeding complications for patients after TAVI.
How similar studies have performed: While the approach of personalized antithrombotic therapy is innovative, similar studies have shown promise in improving outcomes in other cardiovascular interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nieuwegein
- St. Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
Study contacts
- Study coordinator: Christiaan Overduin
- Email: c.overduin@antoniusziekenhuis.nl
- Phone: +31883200931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.