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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:

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

Detailed Description:
Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention
Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Groups and Cohorts
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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
 Drug: Risk of low dose aspirin discontinuation
PPI continuous use; No PPI usePPI
Drug
PPI continuous use; No PPI use


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
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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
Study Population
This is a pharmacoepidemiology study using data from The Health Improvement Network (THIN) primary care database in the UK. Patients aged 50-84 years with evidence of ischemic heart disease or cerebrovascular disease, who were new users of low-dose ASA (75-300 mg/day) and who had received at least two low-dose ASA prescriptions for the secondary prevention of cardiovascular disease or cerebrovascular disease between 2000 and 2007 were identified from THIN. .
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Luis A Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
More Information
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Additional Information:

Publications:

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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
Keywords provided by AstraZeneca:
Discontinuation of low dose ASA,
Secondary cardiovascular prevention,
Acid-suppressing drugs,
Gastrointestinal risk,
Epidemiology
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics