Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05604118
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2022-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-10-20', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet EoxPL differences in amounts (ng) as measured by liquid chromatography with tandem mass spectrometry', 'timeFrame': '4 months', 'description': 'Samples on and off aspirin will be quantified for the 47 most common eoxPL species (as described by Slatter et al, Cell Metabolism 23, 930-944, May 10, 2016) using established liquid chromatography with tandem mass spectrometry (LC-MS/MS). Differences in amounts on and off aspirin will be quantified and tested for statistical significance.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelets', 'phospholipids', 'aspirin'], 'conditions': ['Platelet Dysfunction Due to Aspirin']}, 'descriptionModule': {'briefSummary': 'Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range 20-50 years). Ethical approval, which included informed consent, was from Cardiff University, Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for seven days and then provided a repeat blood sample. Following a 2-month period, participants were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* two-week washout period from any non-steroidal anti-inflammatory drugs (NSAIDs) use.\n* Ability to take aspirin 75 mg once daily for seven days and sampled thereafter, before stopping the aspirin.\n* Willingness to repeat this process after two months and four months of the initial sampling date.\n\nExclusion Criteria:\n\n\\* Recent NSAID use'}, 'identificationModule': {'nctId': 'NCT05604118', 'briefTitle': 'Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin', 'organization': {'class': 'OTHER', 'fullName': 'Cardiff University'}, 'officialTitle': 'Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin', 'orgStudyIdInfo': {'id': 'SMREC16/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin supplemented', 'interventionNames': ['Drug: Aspirin']}, {'type': 'NO_INTERVENTION', 'label': 'Off aspirin'}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': '1 week of aspirin supplementation prior to sampling', 'armGroupLabels': ['Aspirin supplemented']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF144XN', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Sir Geraint Evans Cardiovascular Research Building', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}