Apixaban for the Prevention of Latent Biological Valve Thrombosis

Launched by CLINICAL HOSPITAL CENTRE ZAGREB · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called apixaban can help prevent a specific type of valve problem known as latent bioprosthetic valve thrombosis in patients who have had aortic valve replacement surgery using a special type of valve. Researchers believe that using apixaban, which is an anticoagulant (a blood thinner), may be more effective than using acetylsalicylic acid (a common pain reliever and blood thinner) alone in reducing thickening of the valve leaflets, which can indicate a potential clotting issue.

To participate in this trial, you need to be 65 years or older and have a condition called aortic valve stenosis, where the valve does not open properly. You would also need to be undergoing your first aortic valve replacement surgery with a rapid-deployment bioprosthetic valve. If you are selected, you will take apixaban for three months and then switch to acetylsalicylic acid, while your progress will be monitored with special imaging tests to see how your valve is doing. The trial aims to determine if apixaban is not only more effective but also safe compared to the other treatment option. Importantly, if you have certain medical conditions or are already on specific medications, you may not be eligible to join the study.

Gender

ALL

Eligibility 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