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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
History of Changes
  Purpose

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.


Condition
Nonfatal Myocardial Infarction
Coronary Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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.

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Nonfatal MI or coronary death [ Time Frame: Up to eight years from entry into study cohort ] [ Designated as safety issue: Yes ]

Enrollment: 39513
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360047

Locations
Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Luis A Garcia Rodriguez CEIFE (Centro Español de Investigación Farmacoepidemiológica)
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01360047     History of Changes
Other Study ID Numbers: D961FN00006
Study First Received: May 24, 2011
Last Updated: November 13, 2012
Health Authority: Europe: BfArM (Bundesinstitut fur Arznemittel und Medizineprodukte)

Keywords provided by AstraZeneca:
MI
low dose aspirin
PPI
epidemiology

Additional relevant MeSH terms:
Coronary Disease
Death
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathologic Processes
Ischemia
Necrosis
Aspirin
Proton Pump Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013