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Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone (AWAOMI2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370705
Recruitment Status : Active, not recruiting
First Posted : December 12, 2017
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Poseidon CRO
Information provided by (Responsible Party):
Alfa Wassermann Tunisia

Tracking Information
First Submitted Date  ICMJE November 24, 2017
First Posted Date  ICMJE December 12, 2017
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE January 31, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Change from baseline endothelial function after 6 months [ Time Frame: between base line (day 1) and day 180 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Metric change of the walking distance [ Time Frame: base line, day 90 and day 180: ]
    Metric variation of the walking distance: Clinical assessment as per pain free walking distance and maximum walking distance, measured by walking machine. A significant change for more than 30% of the walking distance at the assessment point, to consider it an improvement while analysing.
  • Change in Von Willebrand Factor (VWF) level [ Time Frame: base line, day 90 and day 180 ]
    Evidence of significant change in VWF level: Serum levels of Von Willebrand Factor will be measured by immunoturbidiometric method. An improvement of the level of VWF blood level by at least 10% in 1st assessment and 30% in last assessment compared to baseline values
  • Assessment of the study medication observance patient's compliance [ Time Frame: 180 days ]
    Compliance will be stated in accordance to the results stated by the patients during remote monitoring at days, 30, 80, 170, and the drug accountability performed by doctors at days 90 and 180. It will be measured in % of the total destined dose expressed in number of intakes and days of treatment.
  • Assessment of safety [ Time Frame: 180 days ]
    Safety will be assessed by checklist questioning during visits and remote interactions, investigators will be responsible for collection and notification to the Sponsor and authorities in case of Serious Adverse Events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Multicentric open-label controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Obstructive Disease
Intervention  ICMJE
  • Drug: Sulodexide
    Sulodexide 250 ULS twice daily per oral route
    Other Name: Vessel
  • Drug: Statin
    Statin 20mg once daily per oral route,
    Other Name: Atorvastatin or equivalent
  • Drug: Antiplatelet Agents
    Antiplatelet therapy 75mg once daily per oral route
    Other Name: lysine acetylsalicylate or equivalent
  • Drug: ACE inhibitor
    ACE inhibitor 20mg once daily per oral route
    Other Name: Captopril or equivalent
Study Arms  ICMJE
  • Active Comparator: 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
    Interventions:
    • Drug: Statin
    • Drug: Antiplatelet Agents
    • Drug: ACE inhibitor
  • Experimental: 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
    Interventions:
    • Drug: Sulodexide
    • Drug: Statin
    • Drug: Antiplatelet Agents
    • Drug: ACE inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2017)
156
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03370705
Other Study ID Numbers  ICMJE AP 12016 AW TN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alfa Wassermann Tunisia
Study Sponsor  ICMJE Alfa Wassermann Tunisia
Collaborators  ICMJE Poseidon CRO
Investigators  ICMJE
Principal Investigator: Imed Frikha, MD STCCV
PRS Account Alfa Wassermann Tunisia
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP