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Aspirin Effectiveness Study

This study is currently recruiting participants.
Verified December 2016 by Prof Dermot Kenny, Royal College of Surgeons, Ireland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113060
First Posted: April 29, 2010
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof Dermot Kenny, Royal College of Surgeons, Ireland
  Purpose
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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland

Resource links provided by NLM:


Further study details as provided by Prof Dermot Kenny, Royal College of Surgeons, Ireland:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
CAD patients
Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention

  Eligibility

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
Criteria

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


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

Locations
Ireland
Beaumont Hospital Recruiting
Dublin 9, Dublin, Ireland
Principal Investigator: Prof. David Foley         
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Investigators
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 Submitted: April 27, 2010
First Posted: April 29, 2010
Last Update Posted: December 19, 2016
Last Verified: December 2016

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics