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Trial record 48 of 88 for:    ASPIRIN AND thromboxane

Aspirin Effectiveness Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01113060
Recruitment Status : Unknown
Verified December 2016 by Prof Dermot Kenny, Royal College of Surgeons, Ireland.
Recruitment status was:  Recruiting
First Posted : April 29, 2010
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Prof Dermot Kenny, Royal College of Surgeons, Ireland

Tracking Information
First Submitted Date April 27, 2010
First Posted Date April 29, 2010
Last Update Posted Date December 19, 2016
Study Start Date April 2010
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2010)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01113060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aspirin Effectiveness Study
Official Title Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts CAD patients
Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 27, 2010)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01113060
Other Study ID Numbers INFACTs2010-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof Dermot Kenny, Royal College of Surgeons, Ireland
Study Sponsor Royal College of Surgeons, Ireland
Collaborators Not Provided
Investigators
Principal Investigator: Prof. Dermot Kenny, MB, BCh, BAO, MD Royal College of Surgeons, Ireland
PRS Account Royal College of Surgeons, Ireland
Verification Date December 2016