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| Name | Class |
|---|---|
| Poseidon CRO | INDUSTRY |
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A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment (antiplatelet therapy; plus ACE inhibitor; plus Statin in patients with cholesterol total level > 1,35 g/l) or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).
Criteria for efficacy evaluation are the assessement of the improvement of the Digital Thermal monitoring between base line (day 1) and day 180 measured by Vendys® and the measurement of the correlation between the Digital Thermal monitoring and the following parameters at base line, day 90 and day 180:
Safety assessment will be done through the collection of the adverse events occurred during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT group | Active Comparator | 78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l |
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| Sulodexide + CT group | Experimental | 78 patients will be treated by :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulodexide | Drug | Sulodexide 250 ULS twice daily per oral route |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline endothelial function after 6 months | Assess the improvement of the Digital Thermal monitoring measured by Vendys®: evaluation of the improvement of Fingertip Digital Thermal Monitoring (DTM) and the detection of a significant change of the FT2 parameters as per Endothelix discriminative values provided by the manufacturer between day 1 and day 180 (±15 days). | between base line (day 1) and day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Metric change of the walking distance | Metric variation of the walking distance: Clinical assessment as per pain free walking distance and maximum walking distance, measured by walking machine. A significant change for more than 30% of the walking distance at the assessment point, to consider it an improvement while analysing. | base line, day 90 and day 180: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imed Frikha, MD | STCCV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InvSite Poseidon0031 | Sfax | 3000 | Tunisia | |||
| InvSite Poseidon 0022 |
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Randomized Multicentric open-label controlled trial
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| Statin | Drug | Statin 20mg once daily per oral route, |
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| Antiplatelet Agents | Drug | Antiplatelet therapy 75mg once daily per oral route |
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| ACE inhibitor | Drug | ACE inhibitor 20mg once daily per oral route |
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| Change in Von Willebrand Factor (VWF) level | Evidence of significant change in VWF level: Serum levels of Von Willebrand Factor will be measured by immunoturbidiometric method. An improvement of the level of VWF blood level by at least 10% in 1st assessment and 30% in last assessment compared to baseline values | base line, day 90 and day 180 |
| Assessment of the study medication observance patient's compliance | Compliance will be stated in accordance to the results stated by the patients during remote monitoring at days, 30, 80, 170, and the drug accountability performed by doctors at days 90 and 180. It will be measured in % of the total destined dose expressed in number of intakes and days of treatment. | 180 days |
| Assessment of safety | Safety will be assessed by checklist questioning during visits and remote interactions, investigators will be responsible for collection and notification to the Sponsor and authorities in case of Serious Adverse Events. | 180 days |
| Sousse |
| 4000 |
| Tunisia |
| InvSite Poseidon0011 | Tunis | 1006 | Tunisia |
| ID | Term |
|---|---|
| C007858 | glucuronyl glucosamine glycan sulfate |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000069059 | Atorvastatin |
| D010975 | Platelet Aggregation Inhibitors |
| C010395 | acetylsalicylic acid lysinate |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D002216 | Captopril |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006401 | Hematologic Agents |
| D011480 | Protease Inhibitors |
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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