A Multicentric Open-label Randomized Controlled Study for Evaluating the Improvement of Endothelial Function in Stage II Peripheral Arterial Obstructive Disease Patients Treated With Sulodexide + Conventional Treatment {CT] Vs CT Alone
Overview
- Phase
- Phase 3
- Intervention
- Statin
- Conditions
- Peripheral Arterial Obstructive Disease
- Sponsor
- Alfa Wassermann Tunisia
- Enrollment
- 156
- Locations
- 3
- Primary Endpoint
- Change from baseline endothelial function after 6 months
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Detailed Description
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: * Von Willebrand factor blood level. * Clinical assessment as per pain free walking distance and maximum walking distance, as measured by walking machine. * Fibrinogen blood level. Also an assessment of the study medication observance (patient's compliance) will be done. Safety assessment will be done through the collection of the adverse events occurred during the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Intermittent claudication.
- •A systolic ankle brachial index ABI \<
- •An age of over 40 years
- •At least one cardiovascular risk factor (active or weaned Smoking, diabetes mellitus, hypertension, lipid disorders, obesity, and erectile dysfunction) or a history of coronary artery disease or transient ischemic stroke or established.
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Exclusion Criteria
- •withdrawal of informed consent
- •participation in another clinical trial with investigational drugs within the last 12 weeks or during the present trial period
- •history of hypersensitivity to the investigational/conventional drugs
- •Non claudicating patients and patients with critical ischemia
- •Arteritis of non-atherosclerotic origin
- •Patients treated with the oxalate or Naftidrofuryl Pentoxifiline Cilostazol or within 3 months that preceded the inclusion
- •Patients receiving other agents that alter the secretion of NO (such as Sildenafil and Tadalafil) less than 2 weeks before inclusion
- •Patients receiving a regimen based on nitrates or molsidomine or Bosentan
- •Patients receiving Anti Vitamin K medication (AVK)
- •Hemorrhagic accident dating less than 15 days before inclusion
Arms & Interventions
CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level \> 1,35 g/l
Intervention: Statin
CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level \> 1,35 g/l
Intervention: Antiplatelet Agents
CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level \> 1,35 g/l
Intervention: ACE inhibitor
Sulodexide + CT group
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
Intervention: Sulodexide
Sulodexide + CT group
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
Intervention: Statin
Sulodexide + CT group
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
Intervention: Antiplatelet Agents
Sulodexide + CT group
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
Intervention: ACE inhibitor
Outcomes
Primary Outcomes
Change from baseline endothelial function after 6 months
Time Frame: between base line (day 1) and day 180
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).
Secondary Outcomes
- Metric change of the walking distance(base line, day 90 and day 180:)
- Change in Von Willebrand Factor (VWF) level(base line, day 90 and day 180)
- Assessment of the study medication observance patient's compliance(180 days)
- Assessment of safety(180 days)