Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT01113060
Status:
UNKNOWN
Last Update Posted:
2016-12-19
First Post:
2010-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspirin Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-16', 'studyFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with non-response to aspirin', 'timeFrame': 'Following a minimum of 3 months of daily aspirin use', 'description': 'Prevalence of non-response to aspirin in coronary artery disease patients in Ireland by measurement of serum thromboxane B2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Aspirin', 'Secondary Prevention'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "Aspirin is an effective medicine for prevention of heart attacks in patients with coronary artery disease and works by preventing clots from forming. In previous studies aspirin has been found to be ineffective in between 2% and 65% of patients but none of these studies have looked specifically at coronary artery disease patients in Ireland. This study is being done to identify the percentage of patients in Ireland whose aspirin is not working effectively and help identify factors that could be used to target interventions to increase aspirin's effectiveness in Irish patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Representative sample of coronary artery disease patients in Ireland receiving aspririn therapy for secondary prevention of cardiovascular events', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Patients with documented coronary artery disease\n* Current treatment with any dose of aspirin daily for a minimum of 3 months\n* Able to provide written informed consent based on competent mental status\n\nExclusion Criteria:\n\n* Myocardial infarction, unstable angina or stroke during the preceding three months\n* Platelet count \\<125,000/mm\n* Known haematological disorders\n* Active malignancy on current chemotherapy or a recent diagnosis of cancer'}, 'identificationModule': {'nctId': 'NCT01113060', 'briefTitle': 'Aspirin Effectiveness Study', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland', 'orgStudyIdInfo': {'id': 'INFACTs2010-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAD patients', 'description': 'Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'state': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Prof. David Foley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'centralContacts': [{'name': 'Mary C De Voe, RN', 'role': 'CONTACT', 'email': 'm.devoe@ucc.ie', 'phone': '+353-21 4901442'}], 'overallOfficials': [{'name': 'Prof. Dermot Kenny, MB, BCh, BAO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal College of Surgeons, Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dermot Kenny', 'investigatorFullName': 'Prof Dermot Kenny', 'investigatorAffiliation': 'Royal College of Surgeons, Ireland'}}}}