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

• Status: Unknown status
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alfa Wassermann Tunisia
• Collaborator: Poseidon CRO
• Treatments: Acetylsalicylic acid lysinate; Angiotensin-Converting Enzyme Inhibitors; Atorvastatin; Captopril; Glucuronyl glucosamine glycan sulfate; Platelet Aggregation Inhibitors

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.