Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT06729034
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06729034
Study Brief:
Protocol Section:
NCT06729034