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NCT01113060 Clinical Trial

Aspirin Effectiveness Study

Coronary Artery Disease Clinical Trial

Official title:
Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01113060
Other study ID # INFACTs2010-001
Secondary ID
Status Recruiting
Phase N/A
First received April 27, 2010
Last updated December 16, 2016
Start date April 2010
Est. completion date April 2017

Study information
Verified date December 2016
Source Royal College of Surgeons, Ireland
Contact Mary C De Voe, RN
Phone +353-21 4901442
Email m.devoe@ucc.ie
Is FDA regulated No
Health authority Ireland: Medical Ethics Research Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Ireland Beaumont Hospital Dublin 9 Dublin

Sponsors (1)
Lead Sponsor Collaborator
Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with non-response to aspirin 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 No
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