A Study of Direct Oral Anticoagulants in Patients with Painful Venous Malformations with Localized Intravascular Coagulation

Launched by OSLO UNIVERSITY HOSPITAL · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called apixaban to see if it can help reduce pain and improve the quality of life for patients with painful venous malformations, which are abnormal clusters of blood vessels that can cause discomfort. The trial has two parts. In the first part, participants will be divided into two groups to receive either apixaban or a placebo (a non-active treatment) in different orders, allowing researchers to compare the effects. Participants will keep a daily diary to track their pain levels and use a quality of life questionnaire to share how they feel before and during treatment.

To be eligible for the trial, participants must be between 18 and 85 years old, have a specific diagnosis of a venous malformation confirmed by an MRI, and experience significant pain that affects daily activities. There are some important health criteria that could exclude someone from participating, such as a history of major bleeding or certain medical conditions. Those who benefit from apixaban in the first part of the study may continue into the second part, where researchers will assess the long-term effects and safety of the drug, initially at a higher dose and then at a lower dose after three months. The trial is not yet recruiting participants, but it offers a chance for individuals with these painful conditions to potentially find relief through this treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be 18-85 years of age at the time of signing the informed consent form (ICF).
• • 2. Participants who have simple VM with LIC. VM must be diagnosed by MRi and LIC is defined as d-dimer \> 2 x upper reference area (21).
• • 3. Patients must experience pain from the malformation, NRS ≥4. Pain is defined as local pain in the malformation, and the participant must have pain that inhibits daily activity or pain during nighttime that interferes with sleep.
• • 4. Body weight over 50 kg. 5. Pregnancy test at time of inclusion must be negative 6. Capable of giving written informed consent
• Exclusion Criteria:
• • 1. History of major bleeding, known disease of the GI tractus with risk of bleeding (ulcera, IBD, tumor), known hemostatic disorder/hemophilia, bariatric surgery or other condition resulting in impaired adsorption of drug, active cancer
• • 2. Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• • 3. Current treatment with platelet inhibitor, any other anticoagulation treatment e.g. unfractionated heparin, low molecular weight heparin (dalteparin, enoxaparin), heparin derivates (fondaparinux), oral anticoagulants (warfarin, dabigatran, rivaroxaban, edoxaban), NSAIDs, cancer therapy with chemotherapy
• • 4. Current treatment with sirolimus
• • 5. Current treatment with azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole)
• • 6. Current treatment with HIV protease inhibitors (e.g., ritonavir)
• • 7. Weight \<50 kg
• • 8. Known hypersensitivity to the active substance or to any of the excipients listed in the SmPC.
• • 9. Impaired renal function (eGFR \< 50 ml/min)
• • 10. Impaired liver function, INR \> 1.3 or aminotransferases \> 3 times upper limit
• • 11. Pregnancy or breastfeeding
• • 12. Low platelet count (\<100 x 109/mL)
• • 13. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures