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Trial record 9 of 1261 for:    ASPIRIN AND Platelet Aggregation

Duration of Platelet Inhibition by Aspirin

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: NCT00671021
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : August 21, 2012
Sponsor:
Information provided by:
Hopital du Sacre-Coeur de Montreal

Tracking Information
First Submitted Date April 30, 2008
First Posted Date May 2, 2008
Last Update Posted Date August 21, 2012
Study Start Date July 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2008)
Platelet aggregation TxA2 formation
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00671021 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 Duration of Platelet Inhibition by Aspirin
Official Title Evaluation of Duration of Platelet Inhibition by Aspirin in a Standard 24-hour Interval Dosing Regimen
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.

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 Probability Sample
Study Population Patients suffering from stable CAD, on chronic ASA therapy
Condition Coronary Artery Disease
Intervention Other: Platelet aggregation
Platelet aggregation TxA2 formation
Study Groups/Cohorts 1
Patients suffering from stable CAD, on chronic ASA therapy
Intervention: Other: Platelet aggregation
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 Completed
Actual Enrollment
 (submitted: May 1, 2008)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00671021
Other Study ID Numbers C.E. 2007-05-42
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hopital du Sacre-Coeur de Montreal
Collaborators Not Provided
Investigators
Principal Investigator: Jean G Diodati, MD Hopital du Sacre-Coeur de Montreal
PRS Account Hopital du Sacre-Coeur de Montreal
Verification Date March 2009