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Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

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ClinicalTrials.gov Identifier: NCT02387450
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Angers.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Sildenafil Drug: Placebo Phase 2 Phase 3

Detailed Description:

Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months.

Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.

Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil
Study Start Date : September 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treated group
Sildenafil, oral, 100mg per day
Drug: Sildenafil
100 mg per day
Other Name: Viagra or revatio

Placebo Comparator: Control group
placebo oral
Drug: Placebo
Placebo with same presentation as the active drug




Primary Outcome Measures :
  1. Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of life Questionnaire [ Time Frame: 3, 6 and 9 months ]
  2. Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event) [ Time Frame: 3, 6 and 9 months ]
    Proportion of Participants with Adverse Events (sildenafil vs. placebo)

  3. Walking capacity (treadmill test) [ Time Frame: 3, 6 and 9 months ]
    treadmill test

  4. Proportion of revascularized patients [ Time Frame: 6 and 9 months ]
    Revascularisation



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ABI<0.90
  • Vascular type claudication
  • stable walking impairment for at least 3 months
  • Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
  • Age > 30 years

Exclusion Criteria:

  • Refuse to participate
  • Administrative protection
  • Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387450


Contacts
Contact: pierre ABRAHAM, MD, PhD +33 241353689 piabraham@chu-angers.fr

Locations
France
Centre hospitalier universitaire
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: pierre Abraham, MD, PhD University Hospital in Angers

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02387450     History of Changes
Other Study ID Numbers: Ongoing recording
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Angers:
Claudication
Maximal walking distance
Morbi-mortality

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents