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

NCT01360047 | Completed

• 1 other identifier: D961FN00006
• Study Type: observational
• Target: 39,513
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonfatal Myocardial Infarction; Coronary Death

Keywords

MI; low dose aspirin; PPI; epidemiology

Outcome Measures

Primary Outcomes (1)

• Nonfatal MI or coronary death

  Up to eight years from entry into study cohort

Study Arms (2)

Cases

Cases with nonfatal MI or coronary death

Controls

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

Eligibility Criteria

• Age: 50 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 50 to 84 years with a first ever prescription of low-dose ASA (defined as 75-300 mg/day) for the secondary prevention of cardiovascular or cerebrovascular events (defined as any previous ischemic cerebrovascular event or ischemic heart disease) from 1 January 2000 to 31 December 2007.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Madrid, Spain

Location

Study Officials

• Luis A Garcia Rodriguez

  CEIFE (Centro Español de Investigación Farmacoepidemiológica)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

ES (1)