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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01814943

Enrollment

39000

Registered

2013-03-20

Start date

2012-11-30

Completion date

2013-05-31

Last updated

2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated Peptic Ulcer

Keywords

Uncomplicated peptic ulcer, Acid-suppressing drugs, Epidemiology

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 84 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users	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	From 1 Januart 2000 till 30 September 2011, an expected average of 6 years

Countries

Spain

Outcome results