Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 7:26 PM
Study NCT ID:
NCT00681759
Status:
COMPLETED
Last Update Posted:
2008-10-31
First Post:
2008-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1836}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-30', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P', 'timeFrame': 'Once at enrollment'}], 'secondaryOutcomes': [{'measure': 'EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization', 'timeFrame': 'Four times daily for three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low Dose Aspirin (LDA)', 'Cardiovascular disease', 'Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '23315343', 'type': 'DERIVED', 'citation': 'Bytzer P, Pratt S, Elkin E, Naesdal J, Sorstadius E. Burden of upper gastrointestinal symptoms in patients receiving low-dose acetylsalicylic acid for cardiovascular risk management: a prospective observational study. Am J Cardiovasc Drugs. 2013 Feb;13(1):27-35. doi: 10.1007/s40256-012-0001-4.'}, {'pmid': '20666569', 'type': 'DERIVED', 'citation': 'Pratt S, Thompson VJ, Elkin EP, Naesdal J, Sorstadius E. The impact of upper gastrointestinal symptoms on nonadherence to, and discontinuation of, low-dose acetylsalicylic acid in patients with cardiovascular risk. Am J Cardiovasc Drugs. 2010;10(5):281-8. doi: 10.2165/11584410-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed written inform consent.\n* Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months.\n* Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events\n\nExclusion Criteria:\n\n* Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.'}, 'identificationModule': {'nctId': 'NCT00681759', 'briefTitle': 'An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin', 'orgStudyIdInfo': {'id': 'D961FC00004'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients who have been prescribed Low Dose Aspirin (LDA) usage in the past 12 months, or those about to begin LDA, will complete a one-time in-office survey using an electronic personal digital assistant (PDA) device (termed SitePro).'}, {'label': '2', 'description': '420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA)'}, {'label': '3', 'description': 'Up to 20 subjects from the three EMA groups will be interviewed to further debrief their experience with Low Dose Aspirin (LDA) and upper GI symptoms.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'city': 'Saint-Laurent', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50008, 'lon': -73.66585}}, {'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tore Lind, MD, Medical Science Director, Nexium', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}