Sulodexide VESSEL for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)

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Recruiting
participants needed

1455
sponsor

Arianna Anticoagulazione Foundation

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Updated on 19 February 2024

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diabetes

renal failure

stroke

anticoagulants

hypertension

anemia

thrombocytopenia

anticoagulant therapy

abuse

nsaids

antiplatelet therapy

thrombosis

secondary prevention

deep vein thrombosis

pulmonary embolism

venous thromboembolism

thromboembolism

embolism

Summary

Show definitions

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.

Description

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%).

Details

Condition	Venous Thromboembolism, Venous Thromboembolism, Anticoagulants, Aged, Thromboembolism, Thromboembolism
Age	75years - 100years
Treatment	Placebo, Sulodexide, Sulodexide and placebo
Clinical Study Identifier	NCT04257487
Sponsor	Arianna Anticoagulazione Foundation
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors
	Patients aged 75 years at the time of enrolment
	Patients with at least one of the known risk factors of bleeding (APPENDIX 1)
	Hypertension
	Renal failure
	Thrombocytopenia
	Diabetes
	Antiplatelet therapy (ASA maximum 140 mg/die)
	Frequent falls (>2 /years)
	Nonsteroidal anti-inflammatory drug
	Liver failure
	Previous Stroke
	Anemia
	Poor anticoagulant control
	Alcohol abuse
	Patients of both sexes
	Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days
	Patients with no other AT indications
	Patients capable and able to provide informed consent
Exclusion Criteria
	Patients aged <75 years at the time of the recruitment visit
	Provoked" index event, which occurred
	Within 3 months of surgery or major trauma
	Bed Rest > 4 days
	Cast / immobility within 3 months
	Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy
	Index event represented by isolated distal DVT or superficial venous thrombosis
	Thrombotic event in sites other than the deep proximal veins of the lower limbs
	Anticoagulant therapy for less than 3 months at the time of enrolment
	Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment
	Recurrent episodes of DVT PE

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Cristina Legnani, BSc, PhD

Primary Contact

Corrado Lodigiani

Italy

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Sulodexide VESSEL for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)