Mesoglycan (Prisma®) Versus Placebo in Secondary Prevention of the Superficial Venous Thrombosis

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to demonstrate the superiority of the mesoglycan (Prisma®), compared to placebo, in reducing the incidence of thromboembolic complications (relapse / extension of superficial venous thrombosis (SVT), deep venous thrombosis (DVT), pulmonary embolism (PE)) in patients who have completed the cycle of therapy of the acute phase after superficial vein thrombosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quovadis Associazione
• Treatments: Dermatan Sulfate

Criteria

Inclusion Criteria:

1. Subjects of both genders, aged> = 18 years,

2. With previous diagnosis of SVT of the lower limbs documented by color-coded duplex ultrasonography (CCDU), which at the onset was at least 5 cm of extension and at least 3 cm from the saphenous junctions (vena magna saphenous and saphenous),

3. who have completed the initial therapeutic cycle with Fondaparinux 2.5 mg / day for 45 days, as required by the most recent Guidelines (ACCP).

4. That screening CCDU does not show deep venous involvement, or an extension of the initial SVT.

Exclusion Criteria:

1. Poor compliance with the treatment of SVT,

2. life expectancy <24 months,

3. anticipated lack of cooperation or impossibility to complete the questionnaires,

4. pregnancy, lactation or programmed pregnancy during the duration of the study,

5. severe locomotor disability or prolonged immobilization,

6. participation in another study in the last 3 months,

7. post-thrombotic syndrome with "Villalta score"> 4,

8. chronic lymphedema of the lower limbs,

9. recent (<3 months) or planned interventional drip-surgery or trans-luminary arterial percutaneous angioplasty (PTA),

10. ongoing dialysis treatment,

11. malabsorption / malnutrition status,

12. chronic and non-suspendable use of anticoagulants, phlebotropics, corticosteroids or NSAIDs, double-antiaggregation or ASA> 160mg / die, centrally acting painkillers,

13. subjects with hypersensitivity to the mesoglycan, heparin or heparinoids, intolerant to galactose or with lactase deficiency, carriers of hemorrhagic diathesis or diseases.