Status:
UNKNOWN
Apixaban for the Prevention of Latent Biological Valve Thrombosis
Lead Sponsor:
Clinical Hospital Centre Zagreb
Conditions:
Aortic Valve Replacement
Antithrombotic Therapy
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Background: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagula...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06184113
Start Date
December 1 2023
End Date
December 1 2025
Last Update
January 3 2024
Active Locations (1)
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1
University Hospital Center Zagreb
Zagreb, Croatia, 10000