Trial | NCT03370705  Report issue

Title

Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    156
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:

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.
Study Started
Jan 31
2019
Primary Completion
Dec 30
2019
Anticipated
Study Completion
Mar 30
2020
Anticipated
Last Update
Dec 02
2019

Drug Sulodexide

Sulodexide 250 ULS twice daily per oral route

  • Other names: Vessel

Drug Statin

Statin 20mg once daily per oral route,

  • Other names: Atorvastatin or equivalent

Drug Antiplatelet Agents

Antiplatelet therapy 75mg once daily per oral route

  • Other names: lysine acetylsalicylate or equivalent

Drug ACE inhibitor

ACE inhibitor 20mg once daily per oral route

  • Other names: Captopril or equivalent

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

Sulodexide + CT group Experimental

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

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.
No Results Posted