Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT00163267
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet activation during and after the intervention', 'timeFrame': '6-12 hours', 'description': 'measured in a chandler loop model'}], 'secondaryOutcomes': [{'measure': 'ABI', 'timeFrame': 'before patients leaves the hospital and at 6 months', 'description': 'as treatment effect'}, {'measure': 'clinical improvement', 'timeFrame': 'up to 6 months', 'description': 'dependent on the additional drug treatment'}, {'measure': 'Safety', 'timeFrame': 'up to 6 months', 'description': 'dependent on the drug treatment with the endovascular treatment'}, {'measure': 'rate of occlusions', 'timeFrame': 'wihtin 6 months', 'description': 'dependent on drug treatment'}]}, 'conditionsModule': {'keywords': ['peripheral arterial intervention', 'atherosclerosis', 'platelets', 'Age above 18'], 'conditions': ['Peripheral Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '24093324', 'type': 'DERIVED', 'citation': 'Strobl FF, Brechtel K, Schmehl J, Zeller T, Reiser MF, Claussen CD, Tepe G. Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease. J Endovasc Ther. 2013 Oct;20(5):699-706. doi: 10.1583/13-4275MR.1.'}]}, 'descriptionModule': {'briefSummary': 'The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.', 'detailedDescription': 'Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.\n\nPatients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peripheral arterial disease which requires intervention\n\nExclusion Criteria:\n\n* Patient already on coumadin or clopidogrel\n* Acute onset of PVD symptoms\n* Patient requiring an operation\n* Contraindication to aspirin and clopidogrel'}, 'identificationModule': {'nctId': 'NCT00163267', 'briefTitle': 'Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study', 'orgStudyIdInfo': {'id': 'mi-1'}, 'secondaryIdInfos': [{'id': 'D.3100340'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ASS + Placebo', 'description': 'control arm', 'interventionNames': ['Drug: clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ASS + Plavix', 'description': 'active drug', 'interventionNames': ['Drug: clopidogrel']}], 'interventions': [{'name': 'clopidogrel', 'type': 'DRUG', 'description': 'Best endovascular treatment either with one or the other drug arm should be investigated', 'armGroupLabels': ['ASS + Placebo', 'ASS + Plavix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital of Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Gunnar Tepe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mirror Trial', 'oldOrganization': 'University of Tuebingen'}}}}