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

Completed

• Conditions: Coronary Death; Nonfatal Myocardial Infarction

• Registration Number: NCT01360073
• Lead Sponsor: AstraZeneca

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42542

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nonfatal MI or coronary death	Up to eight years from entry into study cohort

Trial Locations

Locations (1)

Research Site; 🇸🇪 Molndal, Sweden