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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03370705
• Date of registration: 24/11/2017
• Prospective Registration: Yes
• Primary sponsor: Alfa Wassermann Tunisia
• Public title: Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone AWAOMI2
• Scientific title: A Multicentric Open-label Randomized Controlled Study for Evaluating the Improvement of Endothelial Function in Stage II Peripheral Arterial Obstructive Disease Patients Treated With Sulodexide + Conventional Treatment {CT] Vs CT Alone
• Date of first enrolment: January 31, 2019
• Target sample size: 156
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03370705
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Tunisia

Contacts

• Name: Imed Frikha, MD
• Affiliation: STCCV

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Obstructive Disease

Intervention(s)

Drug: ACE inhibitor

Drug: Statin

Drug: Antiplatelet Agents

Drug: Sulodexide

Primary Outcome(s)

Change from baseline endothelial function after 6 months [Time Frame: between base line (day 1) and day 180]

Secondary Outcome(s)

Assessment of the study medication observance patient's compliance [Time Frame: 180 days]

Assessment of safety [Time Frame: 180 days]

Change in Von Willebrand Factor (VWF) level [Time Frame: base line, day 90 and day 180]

Metric change of the walking distance [Time Frame: base line, day 90 and day 180:]

Secondary ID(s)

AP 12016 AW TN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Poseidon CRO