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

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AstraZeneca

Status

Completed

Conditions

Cardiovascular Prevention

Treatments

Drug: Risk of low dose aspirin discontinuation

Study type

Observational

Funder types

Industry

Identifiers

NCT01888575
D5040N00008

Details and patient eligibility

About

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.

Full description

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

Enrollment

35,604 patients

Sex

All

Ages

50 to 84 years old

Volunteers

No 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.

Trial design

35,604 participants in 2 patient groups

Aspirin discontinuers; Aspirin non-discontinuers
Description:
Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin
Treatment:
Drug: Risk of low dose aspirin discontinuation
Drug
Description:
PPI continuous use; No PPI use

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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