Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-23 @ 6:50 PM
Study NCT ID:
NCT02984293
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2016-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statin Immune Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-29', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be the change in CK levels at the end of the treatment from baseline in both treatment periods.', 'timeFrame': 'Measured at baseline (day 0) and day 29 of both treatment periods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atorvastatin', 'LILRB5', 'Statin intolerance'], 'conditions': ['Drug Intolerance']}, 'referencesModule': {'references': [{'pmid': '25214527', 'type': 'BACKGROUND', 'citation': 'Dube MP, Zetler R, Barhdadi A, Brown AM, Mongrain I, Normand V, Laplante N, Asselin G, Zada YF, Provost S, Bergeron J, Kouz S, Dufour R, Diaz A, de Denus S, Turgeon J, Rheaume E, Phillips MS, Tardif JC. CKM and LILRB5 are associated with serum levels of creatine kinase. Circ Cardiovasc Genet. 2014 Dec;7(6):880-6. doi: 10.1161/CIRCGENETICS.113.000395. Epub 2014 Sep 11.'}, {'pmid': '24897241', 'type': 'BACKGROUND', 'citation': 'Alfirevic A, Neely D, Armitage J, Chinoy H, Cooper RG, Laaksonen R, Carr DF, Bloch KM, Fahy J, Hanson A, Yue QY, Wadelius M, Maitland-van Der Zee AH, Voora D, Psaty BM, Palmer CN, Pirmohamed M. Phenotype standardization for statin-induced myotoxicity. Clin Pharmacol Ther. 2014 Oct;96(4):470-6. doi: 10.1038/clpt.2014.121. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional laboratory signs of muscle damage. However, these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy, reducing its effectiveness. Recent data has highlighted the potential role of immune system in development of statin-induced muscle pain. Variation in the LILRB5 gene has been associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic variability in tolerability and immune response to atorvastatin in healthy volunteers.\n\nThe study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE study. The participants will be healthy, and recruited according to their genotype of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised cross-over study with two treatment periods. During treatment period one, all participants will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire will be completed to assess the tolerability and immune response to the study drug exposure. After four weeks, the study drug is stopped for a washout period of three weeks before cross-over commences. Thereafter, during treatment period two, the alternate study drug will be started, and tolerability will be assessed similar to that in period one. The study will last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-69 years\n* Statin-naïve\n* White European\n* Healthy\n* Acceptable laboratory test results\n\nExclusion Criteria:\n\n* Significant disease\n* Regular drug therapy\n* Recent involvement (\\<30 days) in a CTIMP\n* Inability/unwillingness to comply with the protocol\n* Carry the rare variant of the CKM polymorphism rs11559024\n* Unable to consent\n* Woman of childbearing potential (i.e. premenopausal female capable of becoming pregnant)'}, 'identificationModule': {'nctId': 'NCT02984293', 'acronym': 'ImmunoStat', 'briefTitle': 'Statin Immune Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'Impact of LILRB5 Genotype on Immune Response to Atorvastatin', 'orgStudyIdInfo': {'id': '2016CV05'}, 'secondaryIdInfos': [{'id': '16/ES/0128', 'type': 'OTHER', 'domain': 'East of Scotland Research Ethics Service'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'The participants will receive atorvastatin (80 mg) orally once daily for 28 days.', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The participants will receive matched placebo orally once daily for 28 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin 80 mg once daily for 28 days.', 'armGroupLabels': ['Atorvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily for 28 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'University of Dundee', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Colin NA Palmer, PhD FSB FRSE', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Dundee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'As per GoSHARE tissue bank protocol, the data derived from the existing samples will be returned to the tissue bank for research use.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Tayside', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}