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

Primary Purpose

Peripheral Arterial Obstructive Disease

Status
Unknown status
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Sulodexide
Statin
Antiplatelet Agents
ACE inhibitor
Sponsored by
Alfa Wassermann Tunisia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Obstructive Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • InvSite Poseidon0031
  • InvSite Poseidon 0022
  • InvSite Poseidon0011

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CT group

Sulodexide + CT group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline endothelial function after 6 months
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).

Secondary Outcome Measures

Metric change of the walking distance
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
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
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
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.

Full Information

First Posted
November 24, 2017
Last Updated
November 28, 2019
Sponsor
Alfa Wassermann Tunisia
Collaborators
Poseidon CRO
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1. Study Identification

Unique Protocol Identification Number
NCT03370705
Brief Title
Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
Acronym
AWAOMI2
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alfa Wassermann Tunisia
Collaborators
Poseidon CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Obstructive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Multicentric open-label controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT group
Arm Type
Active Comparator
Arm Description
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
Arm Title
Sulodexide + CT group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sulodexide
Other Intervention Name(s)
Vessel
Intervention Description
Sulodexide 250 ULS twice daily per oral route
Intervention Type
Drug
Intervention Name(s)
Statin
Other Intervention Name(s)
Atorvastatin or equivalent
Intervention Description
Statin 20mg once daily per oral route,
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Agents
Other Intervention Name(s)
lysine acetylsalicylate or equivalent
Intervention Description
Antiplatelet therapy 75mg once daily per oral route
Intervention Type
Drug
Intervention Name(s)
ACE inhibitor
Other Intervention Name(s)
Captopril or equivalent
Intervention Description
ACE inhibitor 20mg once daily per oral route
Primary Outcome Measure Information:
Title
Change from baseline endothelial function after 6 months
Description
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).
Time Frame
between base line (day 1) and day 180
Secondary Outcome Measure Information:
Title
Metric change of the walking distance
Description
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.
Time Frame
base line, day 90 and day 180:
Title
Change in Von Willebrand Factor (VWF) level
Description
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
Time Frame
base line, day 90 and day 180
Title
Assessment of the study medication observance patient's compliance
Description
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.
Time Frame
180 days
Title
Assessment of safety
Description
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.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imed Frikha, MD
Organizational Affiliation
STCCV
Official's Role
Principal Investigator
Facility Information:
Facility Name
InvSite Poseidon0031
City
Sfax
ZIP/Postal Code
3000
Country
Tunisia
Facility Name
InvSite Poseidon 0022
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
InvSite Poseidon0011
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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