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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39513 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Nonfatal Myocardial Infarction Coronary Death

Keywords

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MI low dose aspirin PPI epidemiology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases

Cases with nonfatal MI or coronary death

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis A Garcia Rodriguez

Role: PRINCIPAL_INVESTIGATOR

CEIFE (Centro Español de Investigación Farmacoepidemiológica)

Locations

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Research Site

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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D961FN00006

Identifier Type: -

Identifier Source: org_study_id