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NCT Number: NCT00671021

Duration of Platelet Inhibition by Aspirin

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet aggregation

Other

Platelet aggregation TxA2 formation

Primary outcomes

  1. Platelet aggregation TxA2 formation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2008
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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