Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy
NCT ID: NCT01888575
Last Updated: 2014-05-13
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
35604 participants
OBSERVATIONAL
2012-09-30
2013-06-30
Brief Summary
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To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.
To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.
To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Aspirin discontinuers; Aspirin non-discontinuers
Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin
Risk of low dose aspirin discontinuation
PPI continuous use; No PPI usePPI
Drug
PPI continuous use; No PPI use
No interventions assigned to this group
Interventions
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Risk of low dose aspirin discontinuation
PPI continuous use; No PPI usePPI
Eligibility Criteria
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Inclusion Criteria
* Patients with first prescription of low dose ASA ( see study population description).
* Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.
Exclusion Criteria
* Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
* Incomplete data recording in THIN.
50 Years
84 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Luis A Garcia Rodriguez, MD
Role: PRINCIPAL_INVESTIGATOR
CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
Locations
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Research Site
Madrid, , Spain
Countries
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References
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Cea Soriano L, Rodriguez LA. Risk of Upper Gastrointestinal Bleeding in a Cohort of New Users of Low-Dose ASA for Secondary Prevention of Cardiovascular Outcomes. Front Pharmacol. 2010 Oct 14;1:126. doi: 10.3389/fphar.2010.00126. eCollection 2010.
Garcia Rodriguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011 Feb 22;76(8):740-6. doi: 10.1212/WNL.0b013e31820d62b5. Epub 2011 Jan 26.
Related Links
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Other Identifiers
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D5040N00008
Identifier Type: -
Identifier Source: org_study_id
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