MedTrace Logo

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

NCT03370705 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2019-12-02

No results posted yet for this study

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

Interventions

DRUG

Sulodexide

Sulodexide 250 ULS twice daily per oral route

DRUG

Statin

Statin 20mg once daily per oral route,

DRUG

Antiplatelet Agents

Antiplatelet therapy 75mg once daily per oral route

DRUG

ACE inhibitor

ACE inhibitor 20mg once daily per oral route

Sponsors & Collaborators

  • Poseidon CRO

    collaborator INDUSTRY

  • Alfa Wassermann Tunisia

    lead INDUSTRY

Principal Investigators

  • Imed Frikha, MD · STCCV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-12-30
Completion
2020-03-30

Countries

  • Tunisia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370705 on ClinicalTrials.gov