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

Nonfatal Myocardial Infarction Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360047
• Other study ID #: D961FN00006
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: November 13, 2012
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: BfArM (Bundesinstitut fur Arznemittel und Medizineprodukte)
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39513
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 84 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Death
• Death
• Infarction
• Myocardial Infarction
• Nonfatal Myocardial Infarction

Locations

Country	Name	City	State
Spain	Research Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nonfatal MI or coronary death		Up to eight years from entry into study cohort	Yes