Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease 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 patients with serious coronary heart disease using two UK primary care databases.
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 Patients With Acute Serious Coronary Heart Disease
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: 10.000-15.000 participants
|Ages Eligible for Study:
||50 Years to 84 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Individuals aged 50-84 years who from 1 January 2000 to 31 December 2007 had a documented evidence of a hospitalization for a serious acute coronary event (MI, revascularization of coronary arteries or unstable angina) and who were alive 1 month after this event in two primary care clinical practice databases in the UK: General Practice Research Database (GPRD) and The Health Improvement Network (THIN).
- As above ( study population description).
- All individuals aged 50-84 years with at least one 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01360073
|Madrid, Spain |
|Molndal, Sweden |
||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
Nonfatal MI and coronary death
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Coronary Artery Disease
Arterial Occlusive Diseases
Proton Pump Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Fibrin Modulating Agents