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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01888575

Enrollment

35604

Registered

2013-06-28

Start date

2012-09-30

Completion date

2013-06-30

Last updated

2014-05-13

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

Conditions

Cardiovascular Prevention

Keywords

Discontinuation of low dose ASA,, Secondary cardiovascular prevention,, Acid-suppressing drugs,, Gastrointestinal risk,, 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 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.

Detailed description

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

Interventions

DRUGRisk of low dose aspirin discontinuation

PPI continuous use; No PPI usePPI

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. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use	Up to 1 year.	Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.
Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)	Up to 1 year	Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026