Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication (VALSTAR)
Primary Purpose
Peripheral Arterial Occlusive Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sildenafil 100 mg oral morning dose
Placebo oral morning dose
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease
Eligibility Criteria
Inclusion Criteria:
- Grade I cat 2 or 3 claudication despite optimal medical treatment
- Reporting a vascular claudication history for at least 3 months
- Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes
- Having no cons Sildenafil indication
- Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month
Exclusion Criteria:
- Critical ischemia
- Previous history of myocardial infarction or angina not stabilized
- Amblyopia
- Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil
- Pregnant woman and woman in labor
- Major Person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
- Being in an exclusion period for another biomedical study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sildenafil
Placebo
Arm Description
Single Sildenafil oral morning intake (100mg/day) per day for a total duration of 6 months (Sildenafil 100 mg oral morning dose)
Single Placebo oral morning intake per day for a total duration of 6 months (Placebo oral morning dose)
Outcomes
Primary Outcome Measures
Improvement of Event free survival rate
Event free survival is defined as the time between inclusion date and the date of event occurrence. If no event is observed at the follow-up period, event free survival is defined as the delay of follow-up
Secondary Outcome Measures
Full Information
NCT ID
NCT02930811
First Posted
October 10, 2016
Last Updated
November 2, 2018
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02930811
Brief Title
Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication
Acronym
VALSTAR
Official Title
Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication. A National, Multicentre, Prospective, Randomised, Double-Blind, Placebo-Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The Investigator-Coordinator has moved to Rennes University Hospital. It will be done under the sponsor of Rennes University Hospital : NCT03686306
Study Start Date
undefined (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
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
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD.
Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication.
For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
Single Sildenafil oral morning intake (100mg/day) per day for a total duration of 6 months (Sildenafil 100 mg oral morning dose)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single Placebo oral morning intake per day for a total duration of 6 months (Placebo oral morning dose)
Intervention Type
Drug
Intervention Name(s)
Sildenafil 100 mg oral morning dose
Other Intervention Name(s)
Experimental: Sildenafil
Intervention Description
Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month.
Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months
Intervention Type
Drug
Intervention Name(s)
Placebo oral morning dose
Other Intervention Name(s)
Placebo Comparator: Placebo
Intervention Description
Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month.
Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months
Primary Outcome Measure Information:
Title
Improvement of Event free survival rate
Description
Event free survival is defined as the time between inclusion date and the date of event occurrence. If no event is observed at the follow-up period, event free survival is defined as the delay of follow-up
Time Frame
6 months after the treatment begining
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Grade I cat 2 or 3 claudication despite optimal medical treatment
Reporting a vascular claudication history for at least 3 months
Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes
Having no cons Sildenafil indication
Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month
Exclusion Criteria:
Critical ischemia
Previous history of myocardial infarction or angina not stabilized
Amblyopia
Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil
Pregnant woman and woman in labor
Major Person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
Being in an exclusion period for another biomedical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loukman OMARJEE, MD
Organizational Affiliation
University Hospital, Angers
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28225505
Citation
Omarjee L, Camarzana A, Henni S, Abraham P. Nonrevascularizable buttock claudication improved with Sildenafil: A case report. Medicine (Baltimore). 2017 Feb;96(8):e6186. doi: 10.1097/MD.0000000000006186.
Results Reference
derived
Learn more about this trial
Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication
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