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

NCT03428711 | Completed Phase 2 DMC

• 1 other identifier: METRO
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Superficial Venous Thrombosis of Leg, Secondary Prevention

Keywords

Superficial Venous Thrombosis of Leg; secondary prevention; prophylaxis

Outcome Measures

Primary Outcomes (1)

• Cumulative thrombosis recurrence

  Cumulative occurrence of the first event, with instrumental confirmation, occurring during the study treatment between: recurrence or extension of, asymptomatic or symptomatic, SVT, new DVT (proximal asymptomatic or symptomatic / symptomatic isolated distal), pulmonary embolism (fatal or symptomatic non-fatal).

  12 months

Secondary Outcomes (3)

• Cumulative thrombosis recurrence with distal

  12 months

• Symptoms

  12 months

• VEINES-QOL/ Sym score

  12 months

Study Arms (2)

Placebo Oral Tablet

PLACEBO COMPARATOR

Placebo comparator twice-a-day, for 12 months

Drug: Placebo Oral Tablet

Mesoglycan Oral Tablet

EXPERIMENTAL

a mixture of glycosaminoglycans (mainly heparan-sulphate, dermatan sulfate), inhibitors of thrombin and of Factor Xa and active in restore flow-mediated vasodilation. 50 mg, twice-a-day, for 12 months

Drug: Mesoglycan Oral Tablet

Interventions

Mesoglycan Oral Tablet DRUG

Experimental drug: mesoglycan, already used in the treatment of chronic venous ulcers, is a complex mucopolysaccharide, composed of a mixture of glycosaminoglycans (mainly heparan-sulphate, dermatan sulfate), inhibitors of thrombin and of Factor Xa and active in restore flow-mediated vasodilation. Used in oral formulation, hard capsules, 50 mg, twice-a-day, for 12 months. Reference therapy: placebo, organoleptically indistinguishable from the experimental drug, twice-a-day, for 12 months.

Also known as: Prisma

Mesoglycan Oral Tablet

Placebo Oral Tablet DRUG

Indistinguible placebo tablet

Also known as: placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quovadis Associazione: lead
• Neopharmed Gentili S.p.A.: collaborator

Study Sites (1)

Giuseppe Camporese

Padua, Padova, 35138, Italy

Location

Related Publications (1)

• Camporese G, Bernardi E, Bortoluzzi C, Noventa F, Simioni P; METRO Investigator Study Group. Mesoglycan for the secondary prevention of superficial vein thrombosis: a randomized, controlled, double-blind study (METRO Study)-rationale and protocol. J Thromb Thrombolysis. 2024 Feb;57(2):226-234. doi: 10.1007/s11239-023-02896-6. Epub 2023 Nov 6.

  PMID: 37932589 DERIVED

MeSH Terms

Interventions

mesoglycan

Study Officials

• Giuseppe Camporese, MD

  Quovadis Associazione

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 12, 2018
• Study Start: March 26, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)