Skip to main content
OpenTrials
Completed

NCT Number: NCT01814943

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uncomplicated Peptic Ulcer

Age range

50 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2013
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.