apixaban for Aortic valve disease (patients post transcatheter bioprosthetic aortic valve implantation)

Inclusion criteria

• {"criterion_text":"- Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria"}
• {"criterion_text":"- Residing in Denmark"}
• {"criterion_text":"- Provide written informed consent"}

Exclusion criteria

• {"criterion_text":"- Atrial fibrillation or any other indication for lifelong OAC therapy"}
• {"criterion_text":"- Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g., intracranial haemorrhage or major gastrointestinal bleeding"}
• {"criterion_text":"- Patients with severe renal insufficiency (eGFR <30 mL/min/1.73 m2)"}
• {"criterion_text":"- Patient with absolute indication for anti-thrombotic therapy, e.g., recent PCI"}
• {"criterion_text":"- Iodine contrast allergy or other condition that prohibits CT imaging"}
• {"criterion_text":"- Age <18 years"}
• {"criterion_text":"- Women of childbearing potential, pregnant or nursing"}

Primary endpoints

• {"endpoint_text":"- The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.","definition_or_measurement_approach":"Assessment by cardiac CT at one year after TAVI to determine presence of at least one prosthetic valve leaflet with HALT."}

Secondary endpoints

• {"endpoint_text":"- The combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding at 1 year, 3 years and 5 years after randomization","definition_or_measurement_approach":"Composite clinical endpoint measured at 1, 3 and 5 years after randomization (all-cause mortality, thromboembolic events, life-threatening or major bleeding)."}
• {"endpoint_text":"- The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at 3 months, 1, 3 and 5 years after TAVI","definition_or_measurement_approach":"Assessment by cardiac CT at 3 months, 1, 3 and 5 years after TAVI to count patients with at least one leaflet with HALT."}
• {"endpoint_text":"- Number of prosthetic leaflets with HALT at CT-scan at 3 months, 1 year, 3 and 5 years.","definition_or_measurement_approach":"Count of prosthetic valve leaflets with HALT on CT at specified timepoints (3 months, 1, 3 and 5 years)."}
• {"endpoint_text":"- The clinical endpoint of ischemic stroke verified by cerebrovascular imaging after the TAVI-procedure in patients with vs. without HALT.","definition_or_measurement_approach":"Ischemic stroke verified by cerebrovascular imaging after TAVI compared between patients with and without HALT."}
• {"endpoint_text":"- Any type of stroke – including ischemic and hemorrhagic stroke","definition_or_measurement_approach":"Occurrence of any stroke type (ischemic or hemorrhagic) during follow-up."}
• {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":"Death from any cause during follow-up."}
• {"endpoint_text":"- Cardiovascular mortality as defined in current VARC definition","definition_or_measurement_approach":"Cardiovascular death as per VARC definition during follow-up."}
• {"endpoint_text":"- Major bleeding or life-threatening bleeding","definition_or_measurement_approach":"Major or life-threatening bleeding events as defined in study definitions during follow-up."}
• {"endpoint_text":"- Need for re-intervention (valve-in-valve TAVI, paravalvular leak closure, SAVR)","definition_or_measurement_approach":"Requirement for re-intervention procedures including valve-in-valve TAVI, paravalvular leak closure, or surgical aortic valve replacement (SAVR)."}
• {"endpoint_text":"- Aortic bioprosthetic dysfunction (according to EAPCI/ESC/EACTS definitions)","definition_or_measurement_approach":"Assessment of aortic bioprosthetic dysfunction per EAPCI/ESC/EACTS definitions."}
• {"endpoint_text":"- Rate of bioprosthetic valve failure (according to EAPCI/ESC/EACTS definitions)","definition_or_measurement_approach":"Rate of bioprosthetic valve failure measured per EAPCI/ESC/EACTS definitions."}
• {"endpoint_text":"- NYHA classification","definition_or_measurement_approach":"NYHA functional classification assessments during follow-up."}
• {"endpoint_text":"- Quality of life scores","definition_or_measurement_approach":"Quality of life measured using specified QoL instruments (details in protocol/patient-facing documents)."}

Denmark

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

127

Number Of Sites

2

Number Of Participants

350

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}

Co-sponsors

• Frederiksberg Hospital
• Aarhus Universitet