Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy

May 9, 2014 updated by: AstraZeneca

Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35604

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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. .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year.
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).
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5040N00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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