Duration of Platelet Inhibition by Aspirin

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of Duration of Platelet Inhibition by Aspirin in a Standard 24-hour Interval Dosing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671021
• Other study ID #: C.E. 2007-05-42
• Status: Completed
• Phase: N/A
• First received: April 30, 2008
• Last updated: August 20, 2012
• Start date: July 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

The well established importance of regular aspirin administration stands on firm grounds, as large meta-analyses have shown this therapy to significantly reduce the risk of death. However, not all patients benefit of aspirin administration to the same extent, thus high-lighting a sub-population of patients with inadequate platelet response to ASA. The mechanisms underlying reduced ASA efficacy remain elusive. A recent report has suggested that platelets, long believed to be incapable of de novo protein synthesis, may retain their ability to form the cyclooxygenase enzyme, once it has been inactivated by aspirin. This may explain the inefficacy of the drug to induce sustained platelet inhibition in certain patients.

The current study aims to evaluate, in patients suffering from stable coronary artery disease, the stability of platelet inhibition by aspirin during the normal once daily dosing regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients suffering from stable CAD, on chronic ASA therapy

• Patients willing to participate in the study and to sign the informed consent form

Exclusion Criteria:

• Acute coronary syndrome or revascularization in the last 3 months prior to enrolment

• Concurrent ingestion of nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), clopidogrel, ticlopidine, dipyridamole, warfarin or acenocoumarol

• Frequent use (more than once a week) of non-prescription NSAIDs or drugs containing ASA in the 10 days preceding enrolment

• Major surgical procedure within 1 month before enrolment

• Hemorrhagic diathesis or known platelet dysfunction

• Platelet count outside the 100 to 450 x109/L range for technical reasons

• Hematocrit < 25% or haemoglobin < 100 g/L

• Patient undergoing dialysis for chronic renal failure

• Patient found to be ASA resistant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Platelet aggregation
Platelet aggregation TxA2 formation

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet aggregation TxA2 formation