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

NCT ID: NCT03370705

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-03-30

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.

Conditions

Peripheral Arterial Obstructive Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT group

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

Group Type: ACTIVE_COMPARATOR

Statin

Intervention Type: DRUG

Statin 20mg once daily per oral route,

Antiplatelet Agents

Intervention Type: DRUG

Antiplatelet therapy 75mg once daily per oral route

ACE inhibitor

Intervention Type: DRUG

ACE inhibitor 20mg once daily per oral route

Sulodexide + CT group

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

Group Type: EXPERIMENTAL

Sulodexide

Intervention Type: DRUG

Sulodexide 250 ULS twice daily per oral route

Statin

Intervention Type: DRUG

Statin 20mg once daily per oral route,

Antiplatelet Agents

Intervention Type: DRUG

Antiplatelet therapy 75mg once daily per oral route

ACE inhibitor

Intervention Type: DRUG

ACE inhibitor 20mg once daily per oral route

Interventions

Sulodexide

Sulodexide 250 ULS twice daily per oral route

Intervention Type: DRUG

Statin

Statin 20mg once daily per oral route,

Intervention Type: DRUG

Antiplatelet Agents

Antiplatelet therapy 75mg once daily per oral route

Intervention Type: DRUG

ACE inhibitor

ACE inhibitor 20mg once daily per oral route

Intervention Type: DRUG

Other Intervention Names

Vessel; Atorvastatin or equivalent; lysine acetylsalicylate or equivalent; Captopril or equivalent

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poseidon CRO

INDUSTRY

Sponsor Role: collaborator

Alfa Wassermann Tunisia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imed Frikha, MD

Role: PRINCIPAL_INVESTIGATOR

STCCV

Locations

InvSite Poseidon0031

Sfax, , Tunisia

InvSite Poseidon 0022

Sousse, , Tunisia

InvSite Poseidon0011

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

AP 12016 AW TN

Identifier Type: -

Identifier Source: org_study_id