Duration of Platelet Inhibition by Aspirin

NCT00671021 | Completed DMC

• 1 other identifier: C.E. 2007-05-42
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

platelet aggregation; aspirin

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation TxA2 formation

Study Arms (1)

1

Patients suffering from stable CAD, on chronic ASA therapy

Other: Platelet aggregation

Interventions

Platelet aggregation OTHER

Platelet aggregation TxA2 formation

1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from stable CAD, on chronic ASA therapy

You may qualify if:

• Patients suffering from stable CAD, on chronic ASA therapy
• Patients willing to participate in the study and to sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Platelet Aggregation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Activation; Hemostasis

Study Officials

• Jean G Diodati, MD

  Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 21, 2012

Record last verified: 2009-03

Locations

CA (1)