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

NCT03428711 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2025-05-08

No results posted yet for this study

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

Interventions

DRUG

Mesoglycan Oral Tablet

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.

DRUG

Placebo Oral Tablet

Indistinguible placebo tablet

Sponsors & Collaborators

  • Neopharmed Gentili S.p.A.

    collaborator INDUSTRY

  • Quovadis Associazione

    lead OTHER

Principal Investigators

  • Giuseppe Camporese, MD · Quovadis Associazione

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428711 on ClinicalTrials.gov