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

Cardiovascular Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888575
• Other study ID #: D5040N00008
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: May 9, 2014
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: : Not applicable
• Study type: Observational

Clinical Trial 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.

Description:

Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35604
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 84 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Prevention

Intervention

Drug:
• Risk of low dose aspirin discontinuation
PPI continuous use; No PPI usePPI

Locations

Country	Name	City	State
Spain	Research Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Cea Soriano L, Rodríguez 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. — View Citation

García Rodríguez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No

External Links

•   D5040N00008_CSP.pdf