Key result
Jason trial evaluates oral sulodexide versus placebo for extended secondary VTE prevention in elderly patients.
Why the study?
Sulodexide proved effective against recurrences without major bleeding in a general population, prompting evaluation for extended treatment in elderly patients after a first venous thromboembolism.
Does sulodexide reduce the composite of VTE death and recurrent VTE in elderly patients (≥ 75 years) after at least 3 months of anticoagulation for a first VTE episode?
RCT (n=1,450)
Double-blind
Parallel
Yes
Does sulodexide reduce the composite of VTE death and recurrent VTE in elderly patients (≥ 75 years) after at least 3 months of anticoagulation for a first VTE episode?
This paper describes the design and rationale of the Jason study, an RCT evaluating the efficacy and safety of sulodexide for extended VTE treatment in elderly patients.
Answers are grounded in this paper and cite their sources.
Results of this RCT are awaited before considering sulodexide for extended VTE prevention in elderly; leaves open its efficacy and safety.
) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications. 1450 patients, aged ≥ 75 years, after at least 3 months of anticoagulation treatment for a first VTE episode, are double-blind randomized to receive for 12 months either sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily + indistinguishable placebo, or indistinguishable placebo. Primary outcomes for efficacy are the composite of death for VTE and recurrent VTE, and occurrence of MB for safety. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, and MB + clinically relevant non-MB. The first patient is scheduled to be randomized in May 2020. The study protocol has been approved by AIFA (Agenzia Italiana del Farmaco) and the Ethics Committee of the coordinating center. Written informed consent will be obtained from all patients prior to study participation. Jason study is an investigator-initiated trial, promoted by "Arianna Anticoagulazione" Foundation, Bologna, Italy, and supported by Alfasigma, Bologna, Italy. Study findings will be disseminated to participant centers, at research conferences and in peer-reviewed journals. Trial registration numbers NCT04257487; EudraCT (2019-000570-33).
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Palareti et al. (2020) conducted an RCT in Venous thromboembolism (n=1,450). Sulodexide vs. Placebo was evaluated on Composite of recurrent VTE episodes and VTE-related mortality (efficacy); incidence of major bleeding (safety). The Jason study is a planned randomized controlled trial designed to evaluate the efficacy and safety of two doses of oral sulodexide versus placebo for extended secondary prevention of venous thromboembolism in elderly patients.
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