Clinical trial NCT03370705: Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Arterial Obstructive Disease
Lead sponsor: Alfa Wassermann Tunisia
Sponsor class: INDUSTRY
Collaborators: name: Poseidon CRO
First posted: 2017-12-12
Enrollment: 156
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Multicentric open-label controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Intermittent claudication.
* A systolic ankle brachial index ABI \< 0. 9
* 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
* Heparin treatment or any treatment by low molecular weight heparins during the study for a continuous period of more than 10 days or a cumulative time during the study for more than 21 days.

Primary outcomes:
measure: Change from baseline endothelial function after 6 months
timeFrame: between base line (day 1) and day 180
Secondary outcomes:
measure: Metric change of the walking distance
timeFrame: base line, day 90 and day 180:
measure: Change in Von Willebrand Factor (VWF) level
timeFrame: base line, day 90 and day 180
measure: Assessment of the study medication observance patient's compliance
timeFrame: 180 days
measure: Assessment of safety
timeFrame: 180 days
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: InvSite Poseidon0031
city: Sousse
country: Tunisia
facility: InvSite Poseidon 0022
city: Tunis
country: Tunisia
facility: InvSite Poseidon0011
Study officials:
affiliation: STCCV
name: Imed Frikha, MD
role: PRINCIPAL_INVESTIGATOR
References: