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Anticoagulation with apixaban in venous malformations
EU CTIS ID: 2024-511930-11-00
What this study is testing
To investigate the efficacy of apixaban on pain intensity
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.