Coronary Artery DiseaseNCT01113060
Aspirin Effectiveness Study
An observational study of Coronary Artery Disease, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2010to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Representative sample of coronary artery disease patients in Ireland receiving aspririn therapy for secondary prevention of cardiovascular events
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont Hospital
Dublin, Dublin
Prof. David Foley
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Aspirin, Secondary Prevention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAD patients | Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Following a minimum of 3 months of daily aspirin use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dermot Kenny, Royal College of Surgeons, Ireland
- Investigators
- Prof. Dermot Kenny, MB, BCh, BAO, MD, Principal investigator, Royal College of Surgeons, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113060
- Sponsor's protocol ID
- INFACTs2010-001
- Status last verified
- Dec 2016
- First submitted
- 27 Apr 2010
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland
- ClinicalTrials.gov ID
- NCT01113060
- Acronym / sponsor ID
- INFACTs2010-001
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Aspirin, Secondary Prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD patients | – | –Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Representative sample of coronary artery disease patients in Ireland receiving aspririn therapy for secondary prevention of cardiovascular events
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dermot Kenny, MB, BCh, BAO, MD principal investigator
Royal College of Surgeons, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary C De Voe, RN (+353-21 4901442, m.devoe@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with non-response to aspirin (time frame: Following a minimum of 3 months of daily aspirin use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.