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Completed

NCT Number: NCT01888575

Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy

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 one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.

To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.

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Key information

Conditions

Cardiovascular Prevention

Age range

50 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, Spain

About this study

Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention

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.
  • Patients with first prescription of low dose ASA ( see study population description).
  • Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.

Exclusion criteria

  • Patients aged below age 50 and 85 years and above ( see study population description).
  • Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
  • Incomplete data recording in THIN.

Treatment and study plan

Risk of low dose aspirin discontinuation

Drug

PPI continuous use; No PPI usePPI

Primary outcomes

  1. Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use

    Time frame: Up to 1 year.

    Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.

  2. Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)

    Time frame: Up to 1 year

    Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2013
Registry last updated
May 13, 2014

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.

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