Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-29 @ 8:44 AM
Study NCT ID:
NCT01916720
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529040', 'term': 'darapladib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lp-PLA2 activity in the atherosclerotic plaque removed during carotid endarterectomy', 'timeFrame': '14 +/- 4 days'}], 'secondaryOutcomes': [{'measure': 'Lp-PLA2 mass in plaque removed during the carotid endarterectomy', 'timeFrame': '14 +/- 4 days'}, {'measure': 'Lp-PLA2 mass and activity in blood', 'timeFrame': '14 +/- days'}, {'measure': 'Lipid and Non-Lipid Biomarkers in Plasma', 'timeFrame': '14 +/- days', 'description': 'Lipids: total cholesterol, HDL, LDL, and triglycerides Non-Lipids: hsCRP, CD40L, ICAM-1, E-selectin, PAI-1 antibody, PAI-1 antigen, and MMP-9'}, {'measure': 'Oxidised Lipids and Their Metabolites, and Biomarkers in Plaque', 'timeFrame': '14 +/- 4 days', 'description': 'Oxidised Lipids and Their Metabolites: total lyso-PC, total phospholipid, and total phosphatidylcholine Biomarkers: CD68 (macrophages), CD3 (T cells), CD20 or CD22 (B cells), alpha-actin (smooth muscle cells), CD40L, MMP-2, MMP-9, PAI-1, ICAM-1, IL-6, and Lp-PLA2 (mRNA expression)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'referencesModule': {'availIpds': [{'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/010', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '24586490', 'type': 'DERIVED', 'citation': 'Johnson JL, Shi Y, Snipes R, Janmohamed S, Rolfe TE, Davis B, Postle A, Macphee CH. Effect of darapladib treatment on endarterectomy carotid plaque lipoprotein-associated phospholipase A2 activity: a randomized, controlled trial. PLoS One. 2014 Feb 20;9(2):e89034. doi: 10.1371/journal.pone.0089034. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and plaque, specified biomarkers in blood and plaque and their respective correlation's with Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of SB-480848, and safety and tolerability in this population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, \\>35 years of age\n* Females of childbearing potential must be using approved contraceptive measures\n* Male patients must be willing to abstain from sexual intercourse or use a form of contraception if engaging in sexual intercourse with a woman who could become pregnant\n* Planned carotid endarterectomy within a timeframe compatible with recruitment for the study and able to comply with the requirements of the study, as deemed by the investigator\n* Written, informed consent to participate\n\nExclusion Criteria:\n\n* Recent myocardial infarction (within the previous 4 weeks)\n* Currently taking corticosteroids, warfarin, digoxin or a potent CYP3A4 inhibitor\n* Recent (\\<3 months) or ongoing acute infection or significant trauma associated with bruising and/or taking antibiotics. Prophylactic antibiotics for surgery are allowed\n* Change in dose of lipid-lowering therapy during the previous 4 weeks from randomisation\n* History of chronic liver disease (e.g. cirrhosis, hepatitis) OR ALT OR AST ≥1.5 times the upper limit of normal (ULN) at screening\n* Diagnosis of systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA)\n* Clinically significant anaemia\n* History of severe renal impairment (serum creatinine \\>1.8mg/dL)\n* Unstable angina\n* History of asthma , anaphylaxis or anaphylactoid reactions, severe allergic responses\n* Abuse of alcohol or drugs within the last 6 months\n* Any factor or clinical disease state that, in the investigator's opinion, would preclude completion of a safe surgical procedure and/or completion of the study\n* Use of an investigational drugs within 30 days or 5 half-lives of their last dose prior to starting the study, whichever is the longest"}, 'identificationModule': {'nctId': 'NCT01916720', 'briefTitle': 'Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Effect of the Lp-PLA2 Inhibitor SB-480848 (40, 80mg od) on Carotid Plaque Composition in Patients With Carotid Artery Disease and Planned Carotid Endarterectomy, Stratified for Statin Use and Gender, After 14+/-4 Days Treatment', 'orgStudyIdInfo': {'id': '480848/010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB-480848 40 mg', 'description': 'SB-480848 40 milligrams (mg) once a day (od) for 14 +/- 4 days followed by carotid endarterectomy. SB-480848 40 mg was administered as 2 SB-480848 20 mg tablets plus 2 placebo tablets.', 'interventionNames': ['Drug: SB-480848 40 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB-480848 80 mg', 'description': 'SB-480848 80 mg od for 14 +/- 4 days followed by carotid endarterectomy.SB-480848 80 mg was administered as 4 20 mg SB-480848 tablets.', 'interventionNames': ['Drug: SB-480848 80 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Placebo for 14 +/- 4 days followed by carotid endarterectomy. Placebo was administered as 4 placebo tablets. Placebo tablets were identical in appearance to the SB-480848 20 mg tablets.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SB-480848 40 mg', 'type': 'DRUG', 'description': 'Study Drug', 'armGroupLabels': ['SB-480848 40 mg']}, {'name': 'SB-480848 80 mg', 'type': 'DRUG', 'description': 'Study Drug', 'armGroupLabels': ['SB-480848 80 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Study Drug', 'armGroupLabels': ['Matching Placebo', 'SB-480848 40 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}