Status:
COMPLETED
Mesoglycan (Prisma®) Versus Placebo in Secondary Prevention of the Superficial Venous Thrombosis
Lead Sponsor:
Quovadis Associazione
Collaborating Sponsors:
Neopharmed Gentili S.p.A.
Conditions:
Superficial Venous Thrombosis of Leg, Secondary Prevention
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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 superfi...
Detailed Description
Rationale: SVT is a relatively common clinical condition, with recent evidence of association with the development of DVT and / or pulmonary embolism that has changed the perception of the risk of thi...
Eligibility Criteria
Inclusion
- Subjects of both genders, aged\> = 18 years,
- 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),
- who have completed the initial therapeutic cycle with Fondaparinux 2.5 mg / day for 45 days, as required by the most recent Guidelines (ACCP).
- That screening CCDU does not show deep venous involvement, or an extension of the initial SVT.
Exclusion
- Poor compliance with the treatment of SVT,
- life expectancy \<24 months,
- anticipated lack of cooperation or impossibility to complete the questionnaires,
- pregnancy, lactation or programmed pregnancy during the duration of the study,
- severe locomotor disability or prolonged immobilization,
- participation in another study in the last 3 months,
- post-thrombotic syndrome with "Villalta score"\> 4,
- chronic lymphedema of the lower limbs,
- recent (\<3 months) or planned interventional drip-surgery or trans-luminary arterial percutaneous angioplasty (PTA),
- ongoing dialysis treatment,
- malabsorption / malnutrition status,
- chronic and non-suspendable use of anticoagulants, phlebotropics, corticosteroids or NSAIDs, double-antiaggregation or ASA\> 160mg / die, centrally acting painkillers,
- subjects with hypersensitivity to the mesoglycan, heparin or heparinoids, intolerant to galactose or with lactase deficiency, carriers of hemorrhagic diathesis or diseases.
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT03428711
Start Date
March 26 2018
End Date
December 31 2024
Last Update
May 8 2025
Active Locations (1)
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1
Giuseppe Camporese
Padua, Padova, Italy, 35138