Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Trea… (NCT03370705) | Clinical Trial Compass
UnknownPhase 3
Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
Tunisia156 participantsStarted 2019-01-31
Plain-language 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).
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Change from baseline endothelial function after 6 months