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

Launched by ARIANNA ANTICOAGULAZIONE FOUNDATION · Feb 4, 2020

Keywords

ClinConnect Summary

The Jason Study is a clinical trial looking at a medication called Sulodexide (VESSEL®) to help prevent repeat cases of venous thromboembolism (VTE), which is a condition where blood clots form in the veins, particularly in the legs, and can sometimes travel to the lungs. This study specifically focuses on older adults aged 75 and above who have just had their first episode of a serious blood clot in the leg or lung. Participants will be divided into different groups to receive either Sulodexide in two different doses or a placebo (a sugar pill with no active medication) for a year, to see which treatment works best and is the safest.

To join the study, patients must be at least 75 years old and have experienced their first clot, whether it was caused by known risk factors or not. They should also have undergone at least three months of previous blood-thinning treatment. Participants will be monitored for safety and effectiveness throughout the study, and they will need to provide informed consent, meaning they understand the trial and agree to take part. Overall, this study aims to find better ways to manage blood clot risks in elderly patients, which is especially important given their increased vulnerability to complications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
• • 2. Patients aged ≥75 years at the time of enrolment
• 3. Patients with at least one of the known risk factors of bleeding (APPENDIX 1):
• • 1. Hypertension
• • 2. Renal failure
• • 3. Thrombocytopenia
• • 4. Diabetes
• • 5. Antiplatelet therapy (ASA maximum 140 mg/die)
• • 6. Frequent falls (\>2 /years)
• • 7. Nonsteroidal anti-inflammatory drug
• • 8. Liver failure
• • 9. Previous Stroke
• • 10. Anemia
• • 11. Poor anticoagulant control
• • 12. Alcohol abuse
• • 4. Patients of both sexes.
• • 5. 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.
• • 6. Patients with no other AT indications.
• • 7. Patients capable and able to provide informed consent
• Exclusion Criteria:
• • 1. Patients aged \<75 years at the time of the recruitment visit.
• 2. "Provoked" index event, which occurred:
• • Within 3 months of surgery or major trauma,
• • Bed Rest \> 4 days,
• • Cast / immobility within 3 months.
• • 3. Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
• • 4. Index event represented by isolated distal DVT or superficial venous thrombosis.
• • 5. Thrombotic event in sites other than the deep proximal veins of the lower limbs.
• • 6. Anticoagulant therapy for less than 3 months at the time of enrolment.
• • 7. Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment
• • 8. Recurrent episodes of DVT ± PE