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Aspirin Effectiveness Study

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ClinicalTrials.gov Identifier: NCT01113060
Recruitment Status : Recruiting
First Posted : April 29, 2010
Last Update Posted : December 19, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Coronary Artery Disease

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland
Study Start Date : April 2010
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113060

Contact: Mary C De Voe, RN +353-21 4901442 m.devoe@ucc.ie

Beaumont Hospital Recruiting
Dublin 9, Dublin, Ireland
Principal Investigator: Prof. David Foley         
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Principal Investigator: Prof. Dermot Kenny, MB, BCh, BAO, MD Royal College of Surgeons, Ireland
More Information

Responsible Party: Prof Dermot Kenny, Prof. Dermot Kenny, Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT01113060     History of Changes
Other Study ID Numbers: INFACTs2010-001
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Prof Dermot Kenny, Royal College of Surgeons, Ireland:
Coronary Artery Disease
Secondary Prevention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors