Abstract
How to prevent recurrences after a first venous thromboembolic (VTE) event in elderly patients is still an open issue, especially because of the high bleeding risk of anticoagulation in these patients. The placebo-controlled “Jason” study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel®) 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 NCT 04257487; EudraCT (2019–000570-33).
Highlights
Venous Thromboembolism (VTE), encompassing deep vein thrombosis (DVT) and/or pulmonary embolism (PE), is a frequent and severe disease with an incidence of 1 to 2 per 1000 persons/year [1, 2]
This study showed that treatment for 2 years with oral Sulodexide Vessel® (500 lipasemic units (LSUs), BID) in patients who had suffered from a first idiopathic VTE and had already undergone an adequate period of anticoagulant therapy reduces the risk of thrombotic recurrence by 50% compared to patients receiving placebo, without involving any case of major bleeding
The primary efficacy objective is the composite of recurrent VTE episodes and VTErelated mortality
Summary
Venous Thromboembolism (VTE), encompassing deep vein thrombosis (DVT) and/or pulmonary embolism (PE), is a frequent and severe disease with an incidence of 1 to 2 per 1000 persons/year [1, 2]. The risk of VTE is definitely higher in the elderly population (i.e., older than 75), with an incidence that may reach 0.5 per 100 persons/year [3]. Extended author information available on the last page of the article. Following a first VTE event, anticoagulation therapy for 3–6 months is the mainstay treatment for all patients as an initial and long-term therapy. The extension of anticoagulation beyond this period (extended therapy) is suggested in patients with a high risk of VTE recurrence, provided that the risk of bleeding during anticoagulant therapy is not high, as assessed on individual basis [4]. Among conditions increasing the risk of bleeding there is the elderly population, either because advanced age is in itself a high-risk factor of bleeding and for the more frequent presence of comorbid conditions and associated treatments that may increase the bleeding risk in this population
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