RecruitingRare disease

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication apixaban in patients who have a condition known as venous malformation. Venous malformations are abnormal clusters of blood vessels that can cause pain and other symptoms. In this study, the aim is to see how well apixaban can reduce pain in people with these malformations, especially when there is a problem with blood clotting inside the vessels, known as localized intravascular coagulation.

Participants in the study will receive either apixaban or a placebo. The study will compare the change in pain levels before and after eight weeks of treatment. Additionally, the study will look at changes in blood clotting, quality of life, and the number of blood clots in the venous malformations. The study will also monitor any bleeding episodes that occur during the treatment period.

The study will take place over several months, with an initial treatment phase lasting eight weeks. After this, there will be a follow-up period to assess changes in pain and quality of life three months after adjusting the dose of apixaban. The goal is to better understand how apixaban can help manage pain and improve the quality of life for those with venous malformations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18 and 85 years, confirming a simple venous malformation through MRI, and assessing localized intravascular coagulation with a d-dimer test.
Pain intensity is evaluated using a numerical rating scale (NRS) to ensure it is 4 or higher, indicating it affects daily activities or sleep.
Step 2
Treatment phase 1
The first phase involves taking a film-coated tablet containing apixaban, a medication used to prevent blood clots. The dosage is 5 mg taken orally twice daily.
This phase lasts for 8 weeks, during which the effect of apixaban on pain intensity is monitored.
Step 3
Evaluation after phase 1
After 8 weeks, an evaluation is conducted to compare changes in self-reported pain intensity, coagulation parameters, quality of life, and the amount of thrombi in the venous malformation.
The difference between the effects of apixaban and a placebo is assessed.
Step 4
Treatment phase 2
In the second phase, the dosage of apixaban may be adjusted. The impact on pain intensity and quality of life is monitored for an additional 3 months.
The occurrence and severity of any bleeding episodes are recorded throughout both phases.
Step 5
Final evaluation
A final evaluation is conducted 3 months after the second phase to assess changes in pain intensity and quality of life.
The study aims to conclude by December 31, 2027, with all data collected and analyzed by this date.

Who can join the trial?

4 criteria

Participant must be between 18 and 85 years old at the time of signing the consent form.
The participant must have a simple venous malformation confirmed by MRI (a type of scan that uses magnets and radio waves to create pictures of the inside of the body).
Must have localized intravascular coagulation, which means a blood test called d-dimer is more than 2 times the normal level.
Must have localized pain in the venous malformation that is rated 4 or higher on a pain scale called NRS (Numerical Rating Scale), and this pain must make daily activities difficult or disturb sleep.

Who cannot join the trial?

3 criteria

Patients with conditions other than venous malformation cannot participate. A venous malformation is a type of blood vessel abnormality.
Patients who are not within the specified age range cannot participate. The age range for this study is from 3 to 4 years old.
Patients who are part of vulnerable populations cannot participate. Vulnerable populations include groups that may need special protection, like children or the elderly.

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Verified sites

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Oslo Universitetssykehus HF
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Oslo, Norway

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Investigated drugs

Apixaban is a medication used in this study to see if it can help reduce pain in patients with venous malformations. These malformations can cause blood to clot in the veins, leading to pain. Apixaban works by preventing blood clots from forming, which might help decrease the pain associated with these conditions.

Apixaban

What is already known about the treatment

Apixaban – Apixaban is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating pain associated with venous malformations, particularly those with localized intravascular coagulation. The main therapeutic indication for apixaban in this context is to reduce pain intensity in patients with these conditions. At the molecular level, apixaban works by inhibiting Factor Xa, an enzyme crucial for blood clotting, thereby reducing the formation of clots. It is classified pharmacologically as an anticoagulant.

Investigated diseases

Venous Malformation – Venous malformation is a type of vascular anomaly characterized by abnormally formed veins. These malformed veins can be present anywhere in the body and are typically present at birth, although they may not become apparent until later in life. The condition progresses as the malformed veins can enlarge over time, leading to various symptoms. Common symptoms include pain, swelling, and a bluish discoloration of the skin over the affected area. The malformations can also lead to complications such as clot formation within the veins. The severity and progression of symptoms can vary widely among individuals.