Anticoagulation with apixaban in venous malformations

Phase 1

• Conditions: Venous malformation; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-511930-11-00
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-25
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

History of major bleeding, Lesion or condition if considered a significant risk factor for major bleeding., Contraindications for MRi (cochlear implant, cardiac pacemaker, intracranial clips, claustrophobia), 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), Under cancer therapy, Impaired kidney function (eGFR < 50 ml/min), Impaired liver function (INR > 1,3 or aminotrasferases > 3 times upper limit), Pregnancy or breast feeding, Known hypersensitivity to the active substance or to any of the excipients listed in the SmPC, Low platelet count (<100 x 10e9/mL)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified