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.
Information provided by (Responsible Party):
First received: May 24, 2011
Last updated: November 13, 2012
Last verified: November 2012
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.
Nonfatal Myocardial Infarction
||Observational Model: Cohort
Time Perspective: Retrospective
||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.
Primary Outcome Measures:
- Nonfatal MI or coronary death [ Time Frame: Up to eight years from entry into study cohort ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Cases with nonfatal MI or coronary death
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
Number of Anticipated Subjects: In case-control analysis 5.000-10.000
|Ages Eligible for Study:
||50 Years to 84 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01360047
|Madrid, Spain |
||Luis A Garcia Rodriguez
||CEIFE (Centro Español de Investigación Farmacoepidemiológica)
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 24, 2011
||November 13, 2012
||Europe: BfArM (Bundesinstitut fur Arznemittel und Medizineprodukte)
Keywords provided by AstraZeneca:
low dose aspirin
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Proton Pump Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors