Mesoglycan for the secondary prevention of superficial vein thrombosis: a randomized, controlled, double-blind study (METRO Study)-rationale and protocol.

ABSTRACT: No data is available about pharmacological secondary prevention of superficial vein thrombosis (SVT) despite 10-15% of patients develop venous thromboembolic complications at 3-6 months after an adequate treatment of the acute phase. To verify efficacy and safety of mesoglycan in secondary prevention of SVT recurrence and venous thromboembolic complications. Phase III multicenter, double-blind, randomized, superiority trial comparing mesoglycan 50 mg bid vs placebo in consecutive patients with a SVT extended at least 5 cm, after the initial 45-day treatment course with fondaparinux 2.5 mg once-daily. Primary efficacy outcome: SVT recurrence/extension, symptomatic venous thromboembolism (VTE), asymptomatic proximal deep-vein thrombosis, death. Primary safety outcome: major bleeding. We hypo

SUBMITTER: Camporese G 

PROVIDER: S-EPMC10869363 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature