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Randomized controlled multicenter study comparing steroid therapy plus anticoagulants to steroid therapy alone in deep venous thrombosis of Behçet’s syndrome. AntiCoagulation in Treatment Of thRombosis in Behçet's syndrome (ACTOR).
EU CTIS ID: 2023-510262-27-00
What this study is testing
Assess efficacy and safety of prednisone therapy plus anticoagulant versus prednisone alone (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) in reducing rate of relapse of deep venous thrombosis related to BS without major bleeding.
- Therapeutic exploratory (Phase II)
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
- Age ≥18 years old
- Diagnosis of BS according to the international criteria
- First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
- Written inform consent
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
You likely can't join if
- Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…).
- Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
- Pregnancy or lactation
- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 4000 mg methylprednisolone 4 weeks prior to the inclusion visit
- Severe renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
- Platelet count < 50 x 103/mm3
See the full eligibility criteria
- Age ≥18 years old
- Diagnosis of BS according to the international criteria
- First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
- Written inform consent
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
- Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…).
- Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
- Pregnancy or lactation
- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 4000 mg methylprednisolone 4 weeks prior to the inclusion visit
- Severe renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
- Platelet count < 50 x 103/mm3
- Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit.
- Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
- Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study
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, 65+ 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.