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

Completed

• Conditions: Cardiovascular Prevention
• Interventions: Drug: Risk of low dose aspirin discontinuation

• Registration Number: NCT01888575
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-28
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35604

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aspirin discontinuers; Aspirin non-discontinuers	Risk of low dose aspirin discontinuation	Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain