Using apixaban to prevent valve thrombosis after aortic valve replacement
Comparison of Apixaban and Aspirin for the Prevention of Latent Bioprosthetic Valve Thrombosis After Aortic Valve Replacement Surgery: Study Protocol for a Prospective Randomized Trial
This study is testing if the blood thinner apixaban can help prevent blood clots in older patients who have just had aortic valve replacement surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06184113 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of apixaban, an oral anticoagulant, in preventing latent thrombosis in patients who have undergone aortic valve replacement with bioprosthetic valves. The study is a prospective, open-label, randomized trial involving patients aged 65 and older who do not require long-term anticoagulation. Participants will be assigned to receive either apixaban or acetylsalicylic acid for three months post-surgery, with assessments of valve health conducted through echocardiography and computed tomography. The goal is to determine if apixaban is superior in reducing hypo-attenuated leaflet thickening, which is associated with thrombosis.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 65 or older with aortic valve stenosis who are undergoing their first isolated aortic valve replacement with a rapid deployment bioprosthetic valve.
Not a fit: Patients who require long-term anticoagulation or have contraindications to anticoagulation or antiplatelet therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing aortic valve replacement by reducing the risk of valve thrombosis.
How similar studies have performed: While the approach of using apixaban in this context is novel, similar studies have shown promise in the use of anticoagulants for preventing thrombosis in other settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Men and women aged 65 or older with aortic valve stenosis undergoing successful isolated first-time aortic valve replacement with a rapid deployment bioprosthetic valve * Signed informed consent to participate in the research Exclusion Criteria: * Indication for long-term use of anticoagulant therapy * Indication for dual antiplatelet therapy * Contraindication to anticoagulation or antiplatelet therapy * Inability to start the study drug within the planned randomization period * History of atrial fibrillation * Known hemorrhagic diathesis * Presence of other significant heart pathology * Prior open-heart surgery * Presence of liver failure or other coagulopathy * Aortic valve infective endocarditis * Severe renal failure * Allergy to iodine contrast
Where this trial is running
Zagreb
- University Hospital Center Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Principal investigator: Tomislav Kopjar, MD, PhD — Clinical Hospital Centre Zagreb
- Study coordinator: Tomislav Kopjar, MD, PhD
- Email: tomislav.kopjar@kbc-zagreb.hr
- Phone: +385 (1) 2367 520
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.