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Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy

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ClinicalTrials.gov Identifier: NCT01888575
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date March 18, 2013
First Posted Date June 28, 2013
Last Update Posted Date May 13, 2014
Study Start Date September 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2013)
  • Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use [ Time Frame: Up to 1 year. ]
    Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.
  • Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk) [ Time Frame: Up to 1 year ]
    Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy
Official Title Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention
Brief Summary

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are:

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.

To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.

Detailed Description Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This is a pharmacoepidemiology study using data from The Health Improvement Network (THIN) primary care database in the UK. Patients aged 50-84 years with evidence of ischemic heart disease or cerebrovascular disease, who were new users of low-dose ASA (75-300 mg/day) and who had received at least two low-dose ASA prescriptions for the secondary prevention of cardiovascular disease or cerebrovascular disease between 2000 and 2007 were identified from THIN. .
Condition Cardiovascular Prevention
Intervention Drug: Risk of low dose aspirin discontinuation
PPI continuous use; No PPI usePPI
Study Groups/Cohorts
  • Aspirin discontinuers; Aspirin non-discontinuers
    Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin
    Intervention: Drug: Risk of low dose aspirin discontinuation
  • Drug
    PPI continuous use; No PPI use
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2013)
35604
Original Estimated Enrollment
 (submitted: June 25, 2013)
36000
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged 50-84 years in 2000-2007.
  • Patients with first prescription of low dose ASA ( see study population description).
  • Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.

Exclusion Criteria:

  • Patients aged below age 50 and 85 years and above ( see study population description).
  • Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
  • Incomplete data recording in THIN.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01888575
Other Study ID Numbers D5040N00008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Principal Investigator: Luis A Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
PRS Account AstraZeneca
Verification Date May 2014