Aspirin Effectiveness Study

December 16, 2016 updated by: Prof Dermot Kenny, Royal College of Surgeons, Ireland

Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland

Aspirin is an effective medicine for prevention of heart attacks in patients with coronary artery disease and works by preventing clots from forming. In previous studies aspirin has been found to be ineffective in between 2% and 65% of patients but none of these studies have looked specifically at coronary artery disease patients in Ireland. This study is being done to identify the percentage of patients in Ireland whose aspirin is not working effectively and help identify factors that could be used to target interventions to increase aspirin's effectiveness in Irish patients.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Dublin
      • Dublin 9, Dublin, Ireland
        • Recruiting
        • Beaumont Hospital
        • Principal Investigator:
          • Prof. David Foley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Representative sample of coronary artery disease patients in Ireland receiving aspririn therapy for secondary prevention of cardiovascular events

Description

Inclusion Criteria:

  • Age 18 years or older
  • Patients with documented coronary artery disease
  • Current treatment with any dose of aspirin daily for a minimum of 3 months
  • Able to provide written informed consent based on competent mental status

Exclusion Criteria:

  • Myocardial infarction, unstable angina or stroke during the preceding three months
  • Platelet count <125,000/mm
  • Known haematological disorders
  • Active malignancy on current chemotherapy or a recent diagnosis of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CAD patients
Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with non-response to aspirin
Time Frame: Following a minimum of 3 months of daily aspirin use
Prevalence of non-response to aspirin in coronary artery disease patients in Ireland by measurement of serum thromboxane B2
Following a minimum of 3 months of daily aspirin use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Investigators

  • Principal Investigator: Prof. Dermot Kenny, MB, BCh, BAO, MD, Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 29, 2010

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFACTs2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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