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

Completed
Conditions
Uncomplicated Peptic Ulcer
Registration Number
NCT01814943
Lead Sponsor
AstraZeneca
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 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.

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin usersFrom 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 usersFrom 1 Januart 2000 till 30 September 2011, an expected average of 6 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Research Site

🇪🇸

Madrid, Spain

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