Peripheral Arterial Obstructive DiseasePhase 3AWAOMI2NCT03370705
Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
A Phase 3 study testing Sulodexide, Statin and Antiplatelet Agents in people with Peripheral Arterial Obstructive Disease, run by Alfa Wassermann Tunisia at 3 sites in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Obstructive Disease
- What is being tested?
- Sulodexide, Statin and Antiplatelet Agents
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesTunisia
- Study dates
- 31 Jan 2019to 30 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Tunisia3 sites
InvSite Poseidon0031
Sfax, 3000
InvSite Poseidon 0022
Sousse, 4000
InvSite Poseidon0011
Tunis, 1006
About this study
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
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).
Read the 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.
- Conditions
- Peripheral Arterial Obstructive Disease
- Being tested
- Sulodexide, Statin, Antiplatelet Agents, ACE inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulodexideDrug
Also called Vessel
Sulodexide 250 ULS twice daily per oral route
StatinDrug
Also called Atorvastatin or equivalent
Statin 20mg once daily per oral route,
Antiplatelet AgentsDrug
Also called lysine acetylsalicylate or equivalent
Antiplatelet therapy 75mg once daily per oral route
ACE inhibitorDrug
Also called Captopril or equivalent
ACE inhibitor 20mg once daily per oral route
| Study group | Role | What they receive |
|---|---|---|
| CT group | Active comparator | 78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l Receives: Drug: Statin; Drug: Antiplatelet Agents; Drug: ACE inhibitor |
| Sulodexide + CT group | Experimental | 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 Receives: Drug: Sulodexide; Drug: Statin; Drug: Antiplatelet Agents; Drug: ACE inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: between base line (day 1) and day 180
Secondary outcomes (4)
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.
Measured: base line, day 90 and day 180:
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
Measured: base line, day 90 and day 180
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.
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start31 Jan 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Obstructive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Multicentric open-label controlled trial
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfa Wassermann Tunisia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Poseidon CRO
- Responsible party
- Sponsor
- Investigators
- Imed Frikha, MD, Principal investigator, STCCV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370705
- Sponsor's protocol ID
- AP 12016 AW TN
- Acronym
- AWAOMI2
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2017
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03370705
- Acronym / sponsor ID
- AWAOMI2 / AP 12016 AW TN
- Conditions
- Peripheral Arterial Obstructive Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Alfa Wassermann TunisiaIndustry (pharma, biotech, devices)
- Collaborators
- Poseidon CRO
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Multicentric open-label controlled trial
| Arm | Type | Receives |
|---|---|---|
| CT group | Active comparator | Drug: Statin, Drug: Antiplatelet Agents, Drug: ACE inhibitor78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l |
| Sulodexide + CT group | Experimental | Drug: Sulodexide, Drug: Statin, Drug: Antiplatelet Agents, Drug: ACE inhibitor78 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulodexideAlso: VesselSulodexide 250 ULS twice daily per oral route | Drug | Sulodexide + CT group |
| StatinAlso: Atorvastatin or equivalentStatin 20mg once daily per oral route, | Drug | CT group, Sulodexide + CT group |
| Antiplatelet AgentsAlso: lysine acetylsalicylate or equivalentAntiplatelet therapy 75mg once daily per oral route | Drug | CT group, Sulodexide + CT group |
| ACE inhibitorAlso: Captopril or equivalentACE inhibitor 20mg once daily per oral route | Drug | CT group, Sulodexide + CT group |
Primary outcome
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).
4 secondary outcomes
Metric change of the walking distance
Time frame: base line, day 90 and day 180:
Change in Von Willebrand Factor (VWF) level
Time frame: base line, day 90 and day 180
Assessment of the study medication observance patient's compliance
Time frame: 180 days
Assessment of safety
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imed Frikha, MD principal investigator
STCCV
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulodexide, Statin and Antiplatelet Agents in people with Peripheral Arterial Obstructive Disease, run by Alfa Wassermann Tunisia at 3 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline endothelial function after 6 months (time frame: between base line (day 1) and day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.