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NCT06729034

PHASE2

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

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

There are two parts of the study. In Part 1, the invesitgaotrs want to investigate whether treatment with apixaban improves pain and quality of life in patients with painful venous malformations The participants are randomized to different treatment orders of the two treatment periods with apixaban and placebo. Arm 1 starts apixaban followed by placebo and arm 2 starts with placebo followed by apixaban. Between the treatment sequences there will be a washout period of minimum one week. The participants will register pain and use og pain medication in a diary every day for one week before start of treatment and before evaluation of effect. Also, a quality of life form will be filled out before each consultation. In Part 2, the investigators will investigate long-term effect and safety of apixaban and reduce dose after 3 months to find the minimal effective dose. Part 2 includes participants from Part 1 study who experienced effect of treatment or who agree to continue apixaban treatment. Study start of Part 2 is at the end of Part 1. All participants receive the same dose of apixaban as in part 1 (5 mg twice daily), and after 3 months (visit 2) the dose is reduced to 2.5 mg twice daily.

Official title: A Single-center Blinded Crossover Study Investigating the Efficacy of Apixaban in Patients with Painful Venous Malformations with Localized Intravascular Coagulation

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-01

Completion Date

2031-12-31

Last Updated

2024-12-11

Healthy Volunteers

Conditions

Venous Malformation, Low Flow Anticoagulants

Interventions

DRUG

Apixaban (Eliquis)

5 mg twice daily

DRUG

Placebo

placebo twice daily

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

Locations (1)

Oslo University Hospital

Oslo, Norway