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

Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of First-time Users of Low Dose ASA for Secondary Prevention of Cerebrovascular and Cardiovascular Outcomes.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360047

Enrollment

39513

Registered

2011-05-25

Start date

2011-06-30

Completion date

2011-12-31

Last updated

2012-11-14

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

Conditions

Coronary Death, Nonfatal Myocardial Infarction

Keywords

MI, low dose aspirin, PPI, epidemiology

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 84 Years

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.

Design outcomes

Primary

Measure	Time frame
Nonfatal MI or coronary death	Up to eight years from entry into study cohort

Countries

Spain

Outcome results