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).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

24 Jun 2025 → ongoing

Decision date (initial)

2024-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Assistance Publique – Hôpitaux de Paris (APHP) · Ministry of Health

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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.

Secondary objectives 13

1. To estimate and compare the cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse
2. To estimate and compare the cumulative incidence of major venous thrombosis (Pulmonary embolism, vena cava, Budd-Chiari syndrome, intra-cardiac) relapse
3. To estimate and compare the cumulative incidence of venous repermeabilization
4. To estimate and compare the steroids sparing
5. To estimate and compare the cumulative incidence of major bleeding events
6. To estimate and compare the cumulative incidence of bleeding event
7. To estimate and compare rate of adverse events
8. To estimate and compare the change in quality-of-life
9. To estimate and compare the change in Behcet’s syndrome activity
10. To estimate and compare the overall survival and event free survival
11. To estimate and compare rate of post thrombotic syndrome
12. To estimate and compare the changes in other BS manifestations
13. To estimate and compare the changes in acute-phase reactants

Conditions and MedDRA coding

newly diagnosed or relapsing deep venous thrombosis related to Behçet’s syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥18 years old
2. Diagnosis of BS according to the international criteria
3. First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
4. Written inform consent
5. Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study

Exclusion criteria 9

1. Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…).
2. Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
3. Pregnancy or lactation
4. 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
5. Severe renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
6. Platelet count < 50 x 103/mm3
7. Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit.
8. Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
9. Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of success defined as absence of deep venous thrombosis relapse and major bleeding event, without introduction of additional immunosuppressive medication for BS venous activity at 6 months and following the glucocorticoids tapering.

Secondary endpoints 14

1. Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse within 12 months from randomization
2. Cumulative incidence of major venous thrombosis (i.e other than limbs) relapse within 12 months from randomization
3. Cumulative incidence of venous repermeabilization, assessed by vascular imaging at 6 months. The following ultrasound criteria will be used to determine the absence of repermeabilization flow: partial compressibility of the vein, diminution of the vessel diameter, heterogeneous and hyperechoic thrombus, multiple channels of flow inside the veins, reflux, and collateral circulation.
4. Femoral and popliteal vein reflux is defined as retrograde flow > 1 s after calf and thigh compression release while the patient was in the standing position
5. Measures of corticosteroid sparing: Proportion of patients with a dose ≤ 5 mg/day of prednisone at 6, and 12 months. (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market). Dose at 3, 6 and 12 months. Cumulative dose at 3, 6, and 12 months
6. Cumulative incidence of major bleeding event within 12 months from randomization
7. Cumulative incidence of bleeding event within 12 months from randomization
8. Adverse events (counts, proportions) at 3, 6, and 12 months
9. Change in SF-36 quality-of-life at 3, 6, and 12 months, from baseline
10. Change in Behçet's Disease activity scores BDCAF, BSAS and Physician Global Assessment (PhGA) at 3, 6, and 12 months
11. Overall Survival and event-free-survival within 12 months from randomization
12. Proportion of post thrombotic syndrome according to Villalta’s post-thrombotic syndrome scale and mean changes in Villalta’s post-thrombotic syndrome scale at 6, and 12 months
13. Proportion of remission according to other organs involved at 3, 6, and 12 months
14. Changes in acute-phase reactants at 1, 3, 6, and 12 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

stanislas quenard

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

stanislas quenard

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications