Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT02387450
Status:
UNKNOWN
Last Update Posted:
2015-03-13
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2015-03-02', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life Questionnaire', 'timeFrame': '3, 6 and 9 months'}, {'measure': 'Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event)', 'timeFrame': '3, 6 and 9 months', 'description': 'Proportion of Participants with Adverse Events (sildenafil vs. placebo)'}, {'measure': 'Walking capacity (treadmill test)', 'timeFrame': '3, 6 and 9 months', 'description': 'treadmill test'}, {'measure': 'Proportion of revascularized patients', 'timeFrame': '6 and 9 months', 'description': 'Revascularisation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Claudication', 'Maximal walking distance', 'Morbi-mortality'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIndication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ABI\\<0.90\n* Vascular type claudication\n* stable walking impairment for at least 3 months\n* Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)\n* Age \\> 30 years\n\nExclusion Criteria:\n\n* Refuse to participate\n* Administrative protection\n* Severe renal (clearance \\< 30 ml/min) or hepatic (Child-Pugh C) failure'}, 'identificationModule': {'nctId': 'NCT02387450', 'briefTitle': 'Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil", 'orgStudyIdInfo': {'id': 'Ongoing recording'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treated group', 'description': 'Sildenafil, oral, 100mg per day', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'placebo oral', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra or revatio'], 'description': '100 mg per day', 'armGroupLabels': ['Treated group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo with same presentation as the active drug', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Centre hospitalier universitaire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'pierre ABRAHAM, MD, PhD', 'role': 'CONTACT', 'email': 'piabraham@chu-angers.fr', 'phone': '+33 241353689'}], 'overallOfficials': [{'name': 'pierre Abraham, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital in Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}