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

NCT01888575 | Completed

• 1 other identifier: D5040N00008
• Study Type: observational
• Target: 35,604
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Prevention

Keywords

Discontinuation of low dose ASA,; Secondary cardiovascular prevention,; Acid-suppressing drugs,; Gastrointestinal risk,; Epidemiology

Outcome Measures

Primary Outcomes (2)

• Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use

  Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.

  Up to 1 year.

• Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)

  Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).

  Up to 1 year

Study Arms (2)

Aspirin discontinuers; Aspirin non-discontinuers

Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin

Drug: Risk of low dose aspirin discontinuation

Drug

PPI continuous use; No PPI use

Interventions

Risk of low dose aspirin discontinuation DRUG

PPI continuous use; No PPI usePPI

Aspirin discontinuers; Aspirin non-discontinuers

Eligibility Criteria

• Age: 50 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. .

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Madrid, Spain

Location

Related Publications (2)

• Cea Soriano L, Rodriguez LA. Risk of Upper Gastrointestinal Bleeding in a Cohort of New Users of Low-Dose ASA for Secondary Prevention of Cardiovascular Outcomes. Front Pharmacol. 2010 Oct 14;1:126. doi: 10.3389/fphar.2010.00126. eCollection 2010.

  PMID: 21811460 BACKGROUND

• Garcia Rodriguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011 Feb 22;76(8):740-6. doi: 10.1212/WNL.0b013e31820d62b5. Epub 2011 Jan 26.

  PMID: 21270415 BACKGROUND

Related Links

• D5040N00008\_CSP.pdf

MeSH Terms

Interventions

Risk

Intervention Hierarchy (Ancestors)

Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Luis A Garcia Rodriguez, MD

  CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: June 28, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

ES (1)