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ASPIRIN - Acetylsalicylic acid versus placebo in addition to a local non-steroidal anti-inflammatory drug in the treatment of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years: a controlled randomised, double-blind, cross-over, multicenter trial
EU CTIS ID: 2024-517595-38-00
What this study is testing
To evaluate the efficacy of per os acetylsalicylic acid versus placebo, in addition to a local non-steroidal anti-inflammatory drug, on the pain associated with superficial venous thrombosis in children with superficial venous malformations
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 6 to 17 included
- Weight ≥ 20 kg
- Isolated or combined superficial venous malformation, whatever the topography, confirmed by imaging (MRI, CT, Doppler ultrasound), with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis
- Complicated by acute thrombotic episodes (2 or more in the previous 12 months)
- Written consent of the child's legal representatives or of the participant if over 18 years of age
- Affiliation of a social security scheme
You likely can't join if
- Patients with deep or syndromic venous malformation
- Patients with known G6PD deficiency
- Patients with known mastocytosis
- History of hemarthrosis
- Simultaneous participation in another biomedical study
- Constitutional or acquired haemostasis pathology
See the full eligibility criteria
- Patients aged 6 to 17 included
- Weight ≥ 20 kg
- Isolated or combined superficial venous malformation, whatever the topography, confirmed by imaging (MRI, CT, Doppler ultrasound), with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis
- Complicated by acute thrombotic episodes (2 or more in the previous 12 months)
- Written consent of the child's legal representatives or of the participant if over 18 years of age
- Affiliation of a social security scheme
- Highly effective contraception for young women of childbearing age
- Patients with deep or syndromic venous malformation
- Patients with known G6PD deficiency
- Patients with known mastocytosis
- History of hemarthrosis
- Simultaneous participation in another biomedical study
- Constitutional or acquired haemostasis pathology
- Current treatment affecting haemostasis (anticoagulants, platelet anti-aggregants, oral NSAIDs)
- Frequent bleeding (epistaxis, other) requiring management
- Basic treatment of venous malformation (mTOR inhibitor)
- Active neoplasia or infection (altered coagulation balance)
- Known allergy to acetylsalicylic acid
- Patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome
- Known allergy to NSAIDs
- Patient with Klippel-Trenaunay syndrome or Cloves syndrome
- History of peptic ulcer disease or chronic gastritis
- History of asthma, angioedema, urticaria, or acute rhinitis triggered by diclofenac, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs
- Allergy to one of the excipients of diclofenac gel
- Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds
- Pregnant and breastfeeding women
- Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency
- Methotrexate ≥ 20 mg/week
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.