EDOXABAN for Aortic stenosis | Aortic valve stenosis

Inclusion criteria

• {"criterion_text":"- Age 65-80 years old\n- Successful TAVI for aortic stenosis\n- Signed informed consent form\n- Expected compliance with protocol"}

Exclusion criteria

• {"criterion_text":"- Contraindications for any of the treatment arms\n- Strict indication for antiplatelet drugs (i.e. percutaneous coronary intervention last 12 months, or other)\n- Strict indication for oral anticoagulants (i.e. atrial fibrillation with high stroke risk, recent or recurrent venous thromboembolism, or other)\n- Unable to start study medication within 72 hours after the procedure\n- Drug interactions - Concomitant use of inhibitors of CYP3A4 and P-glycoprotein (such as the antimycotic agents ketoconazole, itraconazole, voriconazole, posaconazole and HIV-protease inhibitors) and inducers of CYP3A4 and P-glycoprotein (phenytoin, carbamazepine, phenobarbital or St. Johns wort)."}

Primary endpoints

• {"endpoint_text":"- Hypo-attenuated leaflet thickening, superiority","definition_or_measurement_approach":""}
• {"endpoint_text":"- Safety Composite, non-inferiority (bleeding, thromboembolic events and all-cause mortality)","definition_or_measurement_approach":"Composite of bleeding, thromboembolic events and all-cause mortality"}

Secondary endpoints

• {"endpoint_text":"- Clinical efficacy, superiority (Composite of of Freedom from all-cause mortality, Freedom from all stroke, Freedom from hospitalization for procedure- or valve-related causes, Freedom from KCCQ overall summary score <45 or decline from baseline of >10 points)","definition_or_measurement_approach":"Composite: freedom from all-cause mortality, freedom from all stroke, freedom from hospitalization for procedure- or valve-related causes, freedom from KCCQ overall summary score <45 or decline from baseline of >10 points"}
• {"endpoint_text":"- Safety Composite, superiority (bleeding, thromboembolic events and all-cause mortality)","definition_or_measurement_approach":"Composite of bleeding, thromboembolic events and all-cause mortality"}
• {"endpoint_text":"- Thromboembolic events, superiority (Composite of myocardial infarction or stroke of any cause)","definition_or_measurement_approach":"Composite of myocardial infarction or stroke of any cause"}
• {"endpoint_text":"- Bleeding events, superiority (Bleeding events according to VARC-3 definitions)","definition_or_measurement_approach":"Bleeding events defined according to VARC-3 definitions"}
• {"endpoint_text":"- All-cause mortality, superiority","definition_or_measurement_approach":"All-cause mortality"}
• {"endpoint_text":"- Safety outcomes in safety population (adverse events, serious adverse events, individual bleeding outcomes)","definition_or_measurement_approach":"Adverse events, serious adverse events, and individual bleeding outcomes in safety population"}
• {"endpoint_text":"- Long-term outcomes at 5 and 10 years (Major Adverse Cardiovascular Events/MACE: The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding)","definition_or_measurement_approach":"MACE composite: cardiac death, aortic valve re-intervention, stroke, myocardial infarction, heart failure hospitalization, and major/life-threatening/disabling bleeding measured at 5 and 10 years"}

Norway

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

1

Number Of Sites

2

Number Of Participants

360

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway