Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy
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ClinicalTrials.gov Identifier: NCT01888575 |
Recruitment Status :
Completed
First Posted : June 28, 2013
Last Update Posted : May 13, 2014
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This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are:
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.
Condition or disease | Intervention/treatment |
---|---|
Cardiovascular Prevention | Drug: Risk of low dose aspirin discontinuation |
Study Type : | Observational |
Actual Enrollment : | 35604 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |
Group/Cohort | Intervention/treatment |
---|---|
Aspirin discontinuers; Aspirin non-discontinuers
Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin
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Drug: Risk of low dose aspirin discontinuation
PPI continuous use; No PPI usePPI |
Drug
PPI continuous use; No PPI use
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- Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use [ Time Frame: Up to 1 year. ]Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.
- Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk) [ Time Frame: Up to 1 year ]Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).

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Ages Eligible for Study: | 50 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients aged 50-84 years in 2000-2007.
- 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 aged below age 50 and 85 years and above ( see study population description).
- Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
- Incomplete data recording in THIN.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888575
Spain | |
Research Site | |
Madrid, Spain |
Principal Investigator: | Luis A Garcia Rodriguez, MD | CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research ) |
Publications:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01888575 |
Other Study ID Numbers: |
D5040N00008 |
First Posted: | June 28, 2013 Key Record Dates |
Last Update Posted: | May 13, 2014 |
Last Verified: | May 2014 |
Discontinuation of low dose ASA, Secondary cardiovascular prevention, Acid-suppressing drugs, Gastrointestinal risk, Epidemiology |
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