NCT01113060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

7 years

First QC Date

April 27, 2010

Last Update Submit

December 16, 2016

Conditions

Keywords

Coronary Artery DiseaseAspirinSecondary Prevention

Outcome Measures

Primary Outcomes (1)

  • 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

    Following a minimum of 3 months of daily aspirin use

Study Arms (1)

CAD patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Representative sample of coronary artery disease patients in Ireland receiving aspririn therapy for secondary prevention of cardiovascular events

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Dublin, Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Prof. Dermot Kenny, MB, BCh, BAO, MD

    Royal College of Surgeons, Ireland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary C De Voe, RN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dermot Kenny

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations