Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death

AstraZeneca

Status: Completed

Conditions: Coronary Death; Nonfatal Myocardial Infarction

Study type: Observational

Funder types: Industry

Identifiers

NCT01360047

D961FN00006

Details and patient eligibility

About

The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time users of low dose ASA for secondary prevention using a UK primary care database.

Full description

Number of Anticipated Subjects: In case-control analysis 5.000-10.000

Enrollment: 39,513 patients

Sex: All

Ages: 50 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• As above (study population description).
• All individuals aged 50-84 years with at least two year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.

Exclusion criteria

• Recorded diagnosis of cancer prior to study start.
• Alcohol abuse or alcohol-related disease prior to study start.
• Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording) which for some individuals will be close to 8 years.

Trial design

39,513 participants in 2 patient groups

Cases

Description:

Cases with nonfatal MI or coronary death

Controls

Description:

Age, sex, and calendar-year matched controls sampled from the original study cohort to be a round number of at least four times the number of cases