apixaban for Venous malformation

Inclusion criteria

• {"criterion_text":"- 1.\tParticipant must be 18–85 years of age at the time of signing the consent form"}
• {"criterion_text":"- The participant must have a simple venous malformation confirmed by MRi"}
• {"criterion_text":"- Localized intravascular coagulation (definition: d-dimer > 2 times upper reference area)"}
• {"criterion_text":"- Localized pain in venous malformation (NRS >/=4) that inhibits daily activity and/or interferes with sleep"}

Exclusion criteria

• {"criterion_text":"- History of major bleeding"}
• {"criterion_text":"- Lesion or condition if considered a significant risk factor for major bleeding."}
• {"criterion_text":"- Contraindications for MRi (cochlear implant, cardiac pacemaker, intracranial clips, claustrophobia)"}
• {"criterion_text":"- Current treatment with platelet inhibitor (prasugrel, ticagrelor, clopidogrel, aspirin), other anticoagulation treatment e.g. unfractionated heparin, low molecular weight heparin (dalteparin, enoxaparin), heparin derivates (fondaparinux), oral anticoagulants (warfarin, dabigatran, rivaroxaban, edoxaban), NSAIDs, sirolimus, azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g., ritonavir)"}
• {"criterion_text":"- Under cancer therapy"}
• {"criterion_text":"- Impaired kidney function (eGFR < 50 ml/min)"}
• {"criterion_text":"- Impaired liver function (INR > 1,3 or aminotrasferases > 3 times upper limit)"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Known hypersensitivity to the active substance or to any of the excipients listed in the SmPC"}
• {"criterion_text":"- Low platelet count (<100 x 10e9/mL)"}

Primary endpoints

• {"endpoint_text":"- Difference between apixaban and placebo in change of self-reported pain intensity before and 8 weeks after starting treatment","definition_or_measurement_approach":"Change in self-reported pain intensity measured before treatment and at 8 weeks after starting treatment (self-reported pain intensity; inclusion criteria reference NRS)."}

Secondary endpoints

• {"endpoint_text":"- Difference between apixaban and placebo in change in coagulation parameters before and 8 weeks after starting treatment (Part 1)","definition_or_measurement_approach":"Change in coagulation parameters measured before treatment and at 8 weeks (Part 1)."}
• {"endpoint_text":"- Difference between apixaban and placebo in change of quality of life before and 8 weeks after starting treatment (Part 1)","definition_or_measurement_approach":"Change in quality of life measured before treatment and at 8 weeks (Part 1)."}
• {"endpoint_text":"- Difference between apixaban and placebo in change of amount of thrombi in venous malformation before and after 8 weeks of treatment (Part 1)","definition_or_measurement_approach":"Change in amount of thrombi in venous malformation measured by imaging before treatment and after 8 weeks (Part 1)."}
• {"endpoint_text":"- Change in pain intensity and quality of life three months after reducing dose (Part 2)","definition_or_measurement_approach":"Assessment of pain intensity and quality of life three months after dose reduction (Part 2)."}
• {"endpoint_text":"- Registering number and severity of bleeding episodes under treatment with apixaban and placebo (Part 1 and 2)","definition_or_measurement_approach":"Recording number and severity of bleeding episodes during treatment periods in Part 1 and Part 2."}
• {"endpoint_text":"- Change in pain intensity 3 months after continuing apixaban 5 mg twice daily (Part 2)","definition_or_measurement_approach":"Change in pain intensity measured 3 months after continuing apixaban 5 mg twice daily (Part 2)."}

Norway

Earliest CTIS Part Ii Submission Date

18-07-2024

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

561

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Norway","full_name":"South-Eastern Norway Regional Health authority","duties_or_roles":"Source of monetary support","organisation_type":""}