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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users
Sponsor: AstraZeneca

Current Primary Outcome:

  • 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. ]
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AstraZeneca

Dates:
Date Received: March 18, 2013
Date Started: November 2012
Date Completion:
Last Updated: June 17, 2013
Last Verified: June 2013