A Phase 3 interventional study of Sulodexide and Statin in Peripheral Arterial Obstructive Disease, sponsored by Alfa Wassermann Tunisia. Status unknown at 3 sites in Tunisia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.
Sponsored by Alfa Wassermann Tunisia · Phase 3, Interventional, and Treatment
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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.
230 studies on the registry are indexed under Arterial Occlusive Diseases; 27 are open to participants now.
This study's planned enrollment of 156 is below the median of 184 across 157 interventional studies indexed under Arterial Occlusive Diseases.
Browse Arterial Occlusive Diseases studies →This is the only study on the registry with Alfa Wassermann Tunisia as lead sponsor.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level \> 1,35 g/l
Drug: Statin · Drug: Antiplatelet Agents · Drug: ACE inhibitor
78 patients will be treated by : * Sulodexide (250ULS, twice daily , oral administration) * Conventional treatment : antiplatelet agents + ACE inhibitor +/- Statin in patients with cholesterol total level \> 1,35 g/l
Drug: Sulodexide · Drug: Statin · Drug: Antiplatelet Agents · Drug: ACE inhibitor
Sulodexide 250 ULS twice daily per oral route
Also known as: Vessel
Statin 20mg once daily per oral route,
Also known as: Atorvastatin or equivalent
Antiplatelet therapy 75mg once daily per oral route
Also known as: lysine acetylsalicylate or equivalent
ACE inhibitor 20mg once daily per oral route
Also known as: Captopril or equivalent
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).
Time frame: between base line (day 1) and day 180
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.
Time frame: base line, day 90 and day 180:
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
Time frame: 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.
Time frame: 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.
Time frame: 180 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2019 (actual). Primary completion is estimated for Dec 2019, 10 months after the start.
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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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