Malformation venous Trials in Disease

Study on Enalapril for Adults with Painful Venous Malformations

This trial is investigating whether Enalapril, a medication commonly known as an ACE-inhibitor, can help reduce pain in adults with venous malformations. ACE-inhibitors work by relaxing blood vessels, which may improve blood flow and reduce pressure in the veins.

Who can participate:

• Adults between 18 and 70 years old
• Must have a confirmed diagnosis through physical examination, ultrasound, and MRI with contrast
• Experience pain rated 4 or higher on a pain scale, which affects daily activities, sleep, and quality of life
• Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for two weeks after treatment
• Must be able to understand Norwegian or English to answer quality of life questionnaires

Who cannot participate:

• Individuals not experiencing pain related to their venous malformation
• Those outside the specified age range

What the trial involves: Participants will take Enalapril Viatris 5 mg tablets orally for 12 months. Throughout the study, researchers will monitor pain levels, use MRI scans to observe any changes in the size of the malformations, and assess quality of life. Any side effects will be carefully recorded to ensure participant safety. The study aims to complete by May 2029.

Study on the Effectiveness of Apixaban for Pain Relief in Patients with Venous Malformations

This trial is testing Apixaban, a medication that prevents blood clots, to see if it can reduce pain in patients whose venous malformations have problems with blood clotting inside the vessels, known as localized intravascular coagulation.

Who can participate:

• Adults between 18 and 85 years old
• Must have a simple venous malformation confirmed by MRI
• Must have localized intravascular coagulation, shown by d-dimer blood test results more than 2 times the normal level
• Experience localized pain in the malformation rated 4 or higher on a pain scale that makes daily activities difficult or disturbs sleep

Who cannot participate:

• Patients with blood vessel conditions other than venous malformation
• Those outside the specified age range
• Individuals from vulnerable populations requiring special protection

What the trial involves: This is a comparison study where participants will receive either Apixaban (5 mg tablets taken twice daily) or a placebo. The initial treatment phase lasts 8 weeks, during which researchers will monitor changes in pain levels, blood clotting parameters, quality of life, and the number of blood clots in the malformations. Any bleeding episodes will be carefully recorded. After 8 weeks, the dosage may be adjusted, and monitoring continues for an additional 3 months. The study aims to conclude by December 2027.

Summary

Both ongoing trials for venous malformations are taking place in Norway, indicating a concentrated research effort in this country. The trials are exploring two different treatment approaches: Enalapril, which works by relaxing blood vessels, and Apixaban, which prevents blood clots. Both medications target pain relief as their primary goal, recognizing that pain is a significant problem for people living with venous malformations.

Notably, one trial focuses specifically on patients with evidence of blood clotting problems within their malformations, while the other includes a broader patient group. Both trials emphasize the importance of pain affecting daily life as a key requirement for participation. The studies use different timeframes, with the Enalapril trial running for 12 months and the Apixaban trial for approximately 5 months, which may reflect different approaches to assessing treatment effectiveness.