Using Sulodexide to prevent blood clots in elderly patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Corrado Lodigiani
  Rozzano, Italy Recruiting

Study contacts

• Study coordinator: Cristina Legnani, BSc, PhD
• Email: c.legnani@fondazionearianna.org
• Phone: 0039 051 2812339

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DoACs vs LMWH for blood flow after knee replacement

  This study tests whether rivaroxaban, apixaban, or LMWH work differently to support blood flow in the legs after total knee replacement in adults.

  Recruiting Military Hospital of Tunis · Tunis, Tunis Governorate · NCT07869615

• Prognostic value of the 2026 AHA/ACC PE classification in ED patients with acute PE

  This study tests whether the 2026 AHA/ACC five-category PE classification helps predict 30-day major adverse pulmonary embolism events in adults with acute PE presenting to the ED.

  Recruiting Marmara University Pendik Training and Research Hospital · Istanbul · NCT07805616

• Screening for blood clots in adults with acute heart failure

  This trial tests whether a guideline-based screening approach can detect pulmonary embolism in adults admitted with acute heart failure.

  Recruiting University Hospital, Angers · Agen and 9 other locations · NCT07499661

• Blood test and software to guide treatment for venous thromboembolism

  This project tests whether a blood-based ctDNA test combined with a software risk score can predict if VTE will come back in adults with cancer-associated DVT or PE who have finished 3–12 months of anticoagulation.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 7 other locations · NCT07399977

• Aspiration thrombectomy with the Symphony or Prodigy devices

  This project will try the Symphony and Prodigy aspiration thrombectomy devices to remove arterial, venous, or pulmonary blood clots in adults.

  Recruiting at 13 sites Imperative Care, Inc. · Huntsville, Alabama and 12 other locations · NCT07350499

• Combining European cohort data to find biomarkers that guide treatment for venous thromboembolism

  This project combines clinical, biological and imaging data from European patient cohorts to try to find biomarkers that predict clot recurrence, bleeding, or death in people with venous thromboembolism.

  Recruiting University Hospital, Brest · Brest · NCT07328152

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.