An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
NCT ID: NCT00681759
Last Updated: 2008-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1836 participants
OBSERVATIONAL
2008-01-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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1
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).
No interventions assigned to this group
2
420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA)
No interventions assigned to this group
3
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months.
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Locations
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Research Site
Brentwood, Tennessee, United States
Research Site
Saint-Laurent, Quebec, Canada
Research Site
Paris, , France
Countries
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References
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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.
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.
Other Identifiers
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D961FC00004
Identifier Type: -
Identifier Source: org_study_id