Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone (AWAOMI2)

Alfa Wassermann

Status and phase: Unknown; Phase 3

Conditions: Peripheral Arterial Obstructive Disease

Treatments: Drug: Antiplatelet Agents; Drug: Statin; Drug: Sulodexide; Drug: ACE inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03370705

AP 12016 AW TN

Details and patient eligibility

About

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).

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

CT group

Active Comparator group

Description:

78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l

Treatment:

Drug: ACE inhibitor

Drug: Statin

Drug: Antiplatelet Agents

Sulodexide + CT group

Experimental group

Description:

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

Treatment:

Drug: ACE inhibitor

Drug: Sulodexide

Drug: Statin

Drug: Antiplatelet Agents