APIXABAN for Roux-en-Y gastric bypass

Inclusion criteria

• {"criterion_text":"- Patients who are screened and approved to undergo laparoscopic ggastric bypass\n- Age 18 years or older"}

Exclusion criteria

• {"criterion_text":"- Symptomatic thrombos at inclusion\n- Use of antiplatelet agent or chronic use of NSAID\n- Known allergy to apixaban\n- Inadequate or lack of contraceptive methods by the patient when relevant\n- Inability to adhere to treatment or to the follow-up visits\n- Current use of anticoagulant medication, such as apixaban, rivaroxaban, edoxaban, dabigatran, acenocoumarol, fenprocoumon, low molecular weighted heparin or heparin\n- Major bleeding defined according to the International Society on Thrombosis and Haemostasis in the 6 months prior to start participation\n- Liver cirrhosis\n- Severe renal insufficiency (eGFR <30 ml/min/1.73 m2)\n- Concurrent use of strong inhibitors or inducers of cytochrome P450 or P-glycoprotein\n- Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than six months, or unwillingness to sign informed consent\n- Known bleeding diathesis or bleeding disorder"}

Primary endpoints

• {"endpoint_text":"- Area under the curve (AUC) of anti-Xa levels comparing at multiple timepoints: baseline (prior to surgery), +/-17 days untill 60days after surgery, +/-3 months after surgery","definition_or_measurement_approach":"Area under the curve (AUC) of anti-Xa levels measured at multiple timepoints: baseline (prior to surgery), around 17 days until 60 days after surgery, and around 3 months after surgery (AUC of anti-Xa concentrations over the sampling timepoints)."}

Secondary endpoints

• {"endpoint_text":"- Measured weight and BMI at follow-up visit +3 months in relation to AUC anti-Xa difference","definition_or_measurement_approach":"Measured body weight and BMI at the 3-month follow-up visit, analysed in relation to differences in AUC of anti-Xa."}
• {"endpoint_text":"- Frequence of major bleeding events as defined per ISTH criteria, and incidence of VTE, including pulmonary embolism and deep vein thrombosis","definition_or_measurement_approach":"Occurrence of major bleeding events classified according to ISTH criteria; incidence of venous thromboembolism events including pulmonary embolism and deep vein thrombosis collected during follow-up."}

Netherlands

Earliest CTIS Part Ii Submission Date

29-04-2025

Latest Decision Or Authorization Date

28-05-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands