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

NCT03370705 | Unknown Phase 3 DMC

• 1 other identifier: AP 12016 AW TN
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

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).

Conditions

Peripheral Arterial Obstructive Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline endothelial function after 6 months

  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).

  between base line (day 1) and day 180

Secondary Outcomes (4)

• 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

Study Arms (2)

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

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

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

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

Interventions

Sulodexide DRUG

Sulodexide 250 ULS twice daily per oral route

Also known as: Vessel

Sulodexide + CT group

Statin DRUG

Statin 20mg once daily per oral route,

Also known as: Atorvastatin or equivalent

CT group; Sulodexide + CT group

Antiplatelet Agents DRUG

Antiplatelet therapy 75mg once daily per oral route

Also known as: lysine acetylsalicylate or equivalent

CT group; Sulodexide + CT group

ACE inhibitor DRUG

ACE inhibitor 20mg once daily per oral route

Also known as: Captopril or equivalent

CT group; Sulodexide + CT group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 receiving a regimen based on nitrates or molsidomine or Bosentan
• Patients receiving Anti Vitamin K medication (AVK)
• 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.

Sponsors & Collaborators

• Alfa Wassermann Tunisia: lead
• Poseidon CRO: collaborator

Study Sites (3)

InvSite Poseidon0031

Sfax, 3000, Tunisia

Location

InvSite Poseidon 0022

Sousse, 4000, Tunisia

Location

InvSite Poseidon0011

Tunis, 1006, Tunisia

Location

MeSH Terms

Interventions

glucuronyl glucosamine glycan sulfate; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Platelet Aggregation Inhibitors; acetylsalicylic acid lysinate; Angiotensin-Converting Enzyme Inhibitors; Captopril

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Hematologic Agents; Protease Inhibitors; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Imed Frikha, MD

  STCCV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Multicentric open-label controlled trial

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 12, 2017
• Study Start: January 31, 2019
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

TU (3)