The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

NCT ID: NCT01814943

Last Updated: 2013-06-18

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

39000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

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 incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA.

To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.

Detailed Description

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The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Conditions

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Uncomplicated Peptic Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with prescription for low dose ASA (75-300 mg/day)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description)

Exclusion Criteria

\- Patients aged below age 50 and 85 years and above ( see study population description)
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)

Other Identifiers

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D5040N00007

Identifier Type: -

Identifier Source: org_study_id

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