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Aspirin Effectiveness Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Royal College of Surgeons, Ireland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier:
NCT01113060
First received: April 27, 2010
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  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:

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

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 2011
Estimated Primary Completion Date: April 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Dermot Kenny, Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT01113060     History of Changes
Other Study ID Numbers: INFACTs2010-001
Study First Received: April 27, 2010
Last Updated: May 7, 2010
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by 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
 Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013