- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01113060
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 Contact
- Name: Mary C De Voe, RN
- Phone Number: +353-21 4901442
- Email: m.devoe@ucc.ie
Study Locations
-
-
Dublin
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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.
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
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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