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

AstraZeneca

Status: Completed

Conditions: Coronary Death; Nonfatal Myocardial Infarction

Study type: Observational

Funder types: Industry

Identifiers

NCT01360073

D961FN00007

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 patients with serious coronary heart disease using two UK primary care databases.

Full description

Number of Anticipated Subjects: In case-control analysis: 10.000-15.000 participants

Enrollment: 42,542 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 one 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.
• 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

Trial design

42,542 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