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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01360047
First received: May 24, 2011
Last updated: November 13, 2012
Last verified: November 2012

May 24, 2011
November 13, 2012
June 2011
December 2011   (final data collection date for primary outcome measure)
Nonfatal MI or coronary death [ Time Frame: Up to eight years from entry into study cohort ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01360047 on ClinicalTrials.gov Archive Site
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Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death
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.

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.

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

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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.

  • Nonfatal Myocardial Infarction
  • Coronary Death
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39513
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01360047
D961FN00006
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AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Luis A Garcia Rodriguez CEIFE (Centro Español de Investigación Farmacoepidemiológica)
AstraZeneca
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP