Using Sulodexide to prevent blood clots in elderly patients

Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism

This study is testing if a medication called Sulodexide can help prevent blood clots in elderly patients who have already had one, while being safer than current treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1455 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: Arianna Anticoagulazione Foundation (Academic / other)
• Locations: 1 site (Rozzano)
• Trial ID: NCT04257487 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Sulodexide (Vessel®) in preventing recurrent venous thromboembolism (VTE) in elderly patients aged 75 and older who have experienced a first episode of proximal deep vein thrombosis or pulmonary embolism. Participants will be randomly assigned to receive either Sulodexide at two different dosages or a placebo for a duration of 12 months. The study aims to determine if Sulodexide can provide a safer alternative for extended treatment while minimizing the risk of major bleeding. The trial focuses on patients with at least one bleeding risk factor, ensuring a targeted approach to this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 75 and older who have had a first episode of proximal DVT or PE and possess at least one bleeding risk factor.

Not a fit: Patients younger than 75 years or those without a history of venous thromboembolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of recurrent blood clots in elderly patients while maintaining safety.

How similar studies have performed: Previous studies have shown promising results with Sulodexide in similar patient populations, indicating potential for success.

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

Where this trial is running

Rozzano

• Corrado Lodigiani — Rozzano, Italy (Recruiting)

Study contacts

• Study coordinator: Cristina Legnani, BSc, PhD

Conditions Venous Thromboembolism; Anticoagulant; Elderly; Venous thromboembolism; Sulodexide