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Use of Sulodexide (VESSEL®) for the prevention of a new episode in elderly patients who have had a first episode of deep vein thrombosis and/or pulmonary embolism
EU CTIS ID: 2024-517796-21-00
What this study is testing
1)Verify the efficacy of the treatment with two different doses of Sulodexide (Vessel®) (treatment A and treatment B) compared to the indistinguishable placebo (treatment C), in reducing the incidence of VTE relapses in elderly patients (age = 75 years) who have suffered from a recent episode of DVT (proximal lower extremity) and / or PE, by 35% compared to placebo. 2)Verify the safety of the aforementioned therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not > 3%)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with a first event of proximal lower extremity DVT and / or PE,
- Patients aged =>75 years at the time of enrolment
- Pazienti with at least one of the known risk factors of bleeding (APPENDIX 1): a.- Hypertension - Previous non-minor bleeding event - Renal failure (< 60 ml/min) - Thrombocytopenia (<100,000 mm3) - Diabetes - Ongoing ASA therapy (maximum 140 mg/day) - Frequent falls (>2 per year) - Use of non-steroidal anti-inflammatory drugs - Liver failure (transaminases > 3 times the upper reference limit) - Previous cerebral stroke - Anemia (hemoglobin< 100 g/L) - Insufficient control of anticoagulant therapy (TTR: Time in range < 60%) - 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.
You likely can't join if
- Patients aged <75 years at the time of the recruitment visit.
- Presence of other clinical conditions requiring anticoagulant therapy.
- Presence of Inferior vena cava (IVC) filter.
- Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day.
- All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH).
- Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)
See the full eligibility criteria
- Patients with a first event of proximal lower extremity DVT and / or PE,
- Patients aged =>75 years at the time of enrolment
- Pazienti with at least one of the known risk factors of bleeding (APPENDIX 1): a.- Hypertension - Previous non-minor bleeding event - Renal failure (< 60 ml/min) - Thrombocytopenia (<100,000 mm3) - Diabetes - Ongoing ASA therapy (maximum 140 mg/day) - Frequent falls (>2 per year) - Use of non-steroidal anti-inflammatory drugs - Liver failure (transaminases > 3 times the upper reference limit) - Previous cerebral stroke - Anemia (hemoglobin< 100 g/L) - Insufficient control of anticoagulant therapy (TTR: Time in range < 60%) - 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.
- Patients aged <75 years at the time of the recruitment visit.
- Presence of other clinical conditions requiring anticoagulant therapy.
- Presence of Inferior vena cava (IVC) filter.
- Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day.
- All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH).
- Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)
- Known carriers of one or more of the following thrombophilic alterations: deficiency of physiological anticoagulants (antithrombin, protein C, protein S).
- Presence of inflammatory bowel disease in acute;
- Cardiorespiratory failure (New York Heart Association class 3 or 4).
- Patients incapacitated or refusing to sign the informed consent.
- Patients with life expectancy under 1 year.
- Active cancer.
- Patients residing in a disadvantaged geographical area.
- Patient already enrolled in other clinical trials.
- Pazienti con pressione polmonare sistolica > 40 mm Hg (limite superiore previsto per anziani);
- Contraindication to Sulodexide (VESSEL®) and Placebo
- Index event represented by severe PE, with life threatening risk or which involved thrombolytic therapy.
- Index event represented by isolated distal DVT or superficial venous thrombosis.
- Thrombotic event that involved sites other than the deep proximal veins of the lower limbs.
- Anticoagulant therapy in progress for less than 3 months at the time of enrolment.
- Discontinuation of anticoagulant therapy for over three months
- Recurrent episodes of DVT ± PE (do not consider previous superficial venous thrombosis or isolated distal venous thrombosis as an exclusion criteria);
- Presence of severe post-thrombotic syndrome (Villalta score >15 or presence ofvenous ulcer).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.