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OpenTrials
Completed

NCT Number: NCT01360047

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

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.

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Key information

Conditions

Nonfatal Myocardial Infarction Coronary Death

Age range

50 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Nonfatal MI or coronary death

    Time frame: Up to eight years from entry into study cohort

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 25, 2011
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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