The study aims at optimizing extended management of elderly patients (\> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients were randomized to receive three different treatment: Sulodexide 250 mg BIS in die; Sulodexide 500 BID in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with Sulodexide (Vessel®) in the secondary prevention of Deep Vein Thrombosis / Pulmonary Embolism (DVT/PE) recurrence.
This prospective cohort study aims to assess the efficacy and safety of the extended treatment with Sulodexide (Vessel®) in the secondary prevention of DVT / PE recurrence in elderly outpatients (≥ 75 years old at the time of inclusion) ), with at least one of the known bleeding risk factor, who had a first episode of lower extremity proximal DVT and / or PE, idiopathic or associated with weak or removed risk factors, and who have received standard treatment with any oral anticoagulant drug lasting at least 3 months. The study seeks to verify the safety of the Sulodexide therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not \> 3%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,455
2 soft capsules of Vessel® 250 LSU BID for 12 months
1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
Sugar pill manufactured to mimic sulodexide 250 LSU
Corrado Lodigiani
Rozzano, Italy
RECRUITINGNumber and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients
Time frame: From date of enrollment until the date of first documented event assessed up to 12 months
Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)
Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients
Time frame: From date of enrollment until the date of first documented event assessed up to 12 months
Number of and rate of thromboembolic events
Transient ischemic attack (TIA), Stroke, Myocardial infarction will be recorded in all patients
Time frame: From date of enrollment until the date of first documented event assessed up to 12 months
Presence of severe post-thrombotic syndrome according to Villalta Score
Patient with deep vein thrombosis as index event will be evaluated, at the and of follow-up, applying Villalta score, commonly used to diagnose post-thrombotic syndrome in the subacute phase of thrombosis. The presence of venous ulcer of the leg or a score \> of 15 points indicate the occurrence of severe post-thrombotic syndrome. The maximum score is 33. The score from 5 to 9 points indicate mild post-thrombotic syndrome and from 10 to 15 points indicate moderate post-thrombotic syndrome
Time frame: 12 months
Number and rate of non major bleeding complications
In all patients will be recorded any sign or symptom of hemorrhage that does not fit the criteria for the definition of major bleeding but does meet at least one of the following criteria: 1)requiring medical intervention by a healthcare professional; 2) leading to hospitalization or increased level of care;3) prompting a face to face evaluation
Time frame: From date of enrollment until the date of first documented event assessed up to 12 months
Number and rate of dead patients (overall mortality)
VTE-related death; cardiovascular related-death; bleeding-related death; death for: cancer, infectious disease and unknown cause; sudden death will be recorded in all patients
Time frame: From date of enrollment until the date of first documented event assessed up to 12 months
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