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

NCT ID: NCT01888575

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35604 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-06-30

Brief Summary

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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

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

Conditions

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Cardiovascular Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aspirin discontinuers; Aspirin non-discontinuers

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

Risk of low dose aspirin discontinuation

Intervention Type DRUG

PPI continuous use; No PPI usePPI

Drug

PPI continuous use; No PPI use

No interventions assigned to this group

Interventions

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Risk of low dose aspirin discontinuation

PPI continuous use; No PPI usePPI

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis A Garcia Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research Site

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 21811460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21270415 (View on PubMed)

Related Links

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Other Identifiers

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D5040N00008

Identifier Type: -

Identifier Source: org_study_id

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