Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death
Completed
- Conditions
- Nonfatal Myocardial InfarctionCoronary Death
- Registration Number
- NCT01360047
- 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39513
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.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇪🇸Madrid, Spain