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

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ClinicalTrials.gov Identifier: NCT01360047
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Nonfatal Myocardial Infarction Coronary Death

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

Study Design

Study Type : Observational
Actual Enrollment : 39513 participants
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.
Study Start Date : June 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Aspirin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Nonfatal MI or coronary death [ Time Frame: Up to eight years from entry into study cohort ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01360047     History of Changes
Other Study ID Numbers: D961FN00006
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by AstraZeneca:
MI
low dose aspirin
PPI
epidemiology

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