The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

June 17, 2013 updated by: AstraZeneca

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 incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA.

To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.

Study Overview

Status

Completed

Conditions

Detailed Description

The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Study Type

Observational

Enrollment (Actual)

39000

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

Patients aged 50-84 yrs who had a first prescription of low-dose ASA (75-300mg/day) for secondary cardiovascular or cerebrovascular prevention in 2000-2007 in The Health Improvement Network database in the UK. Patients had to be enrolled with their PCP (Primary Care Physician) for at least 2 years and have a health contact in the year prior. Patients with use of aspirin ever recorded in the database before start of follow-up as well as patient with cancer or alcohol abuse were excluded. Individuals were followed up until the earliest occurrence of one of the following endpoints; first recorded diagnosis of uncomplicated peptic ulcer, canser, alcohol abuse or alcohol related disease, reaching the age of 85 years old, date of last practice data collection, death or end of follow-up ( 30 September 2011).Patient records were manually reviewed to validate cases.

Description

Inclusion Criteria:

- Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description)

Exclusion Criteria:

- Patients aged below age 50 and 85 years and above ( see study population description)

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
Patients with prescription for low dose ASA (75-300 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users
Time Frame: From 1 January 2000 till 30 September 2011, an expected average of 6 years.
From 1 January 2000 till 30 September 2011, an expected average of 6 years.
Risk (hazard ratio) of developing uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users
Time Frame: From 1 Januart 2000 till 30 September 2011, an expected average of 6 years
From 1 Januart 2000 till 30 September 2011, an expected average of 6 years

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

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

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5040N00007

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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