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

NCT01360073 | Completed

• 1 other identifier: D961FN00007
• Study Type: observational
• Target: 42,542
• Locations: 2 countries
• Sites: 2

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.

Conditions

Nonfatal Myocardial Infarction; Coronary Death

Keywords

MI; low dose aspirin; PPI; epidemiology; Nonfatal MI and coronary death

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

Individuals aged 50-84 years who from 1 January 2000 to 31 December 2007 had a documented evidence of a hospitalization for a serious acute coronary event (MI, revascularization of coronary arteries or unstable angina) and who were alive 1 month after this event in two primary care clinical practice databases in the UK: General Practice Research Database (GPRD) and The Health Improvement Network (THIN).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Madrid, Spain

Location

Research Site

Mölndal, Sweden

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: July 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); SE (1)