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Danish Aspirin Resistance Trial - Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Danish Research Agency
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00389129
First received: October 17, 2006
Last updated: December 10, 2007
Last verified: December 2007

October 17, 2006
December 10, 2007
November 2006
Not Provided
Platelet aggregation (as determined by 3 point-of-care tests and by serum-thromboxane A2 + urine 11-dehydro thromboxane B2) is measured once daily for 4 days after one week of treatment with aspirin 75 mg/day
Same as current
Complete list of historical versions of study NCT00389129 on ClinicalTrials.gov Archive Site
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Danish Aspirin Resistance Trial - Pilot Study
Comparative Evaluation of Aspirin Resistance With Point-of-Care Testing - Danish Aspirin Resistance Trial (DANART) - Pilot Study

Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. At present, no international consensus exists on how to measure "aspirin resistance". The purpose of this study is to compare different methods for detecting "aspirin resistance". A classic but cumbersome way of evaluating platelet function will be compared to newer, easy-handling point-of-care tests. We hypothesize that one or more point-of-care tests will prove to be superior to the classic platelet function test in detecting aspirin resistance.

Platelets play a major role in arterial thrombus formation - the cause of cardiovascular death, acute myocardial infarction and ischemic stroke and the number one killer in the Western World. Binding the COX enzyme platelet aggregation is inhibited by aspirin, and as prophylaxis against death, myocardial infarction and stroke aspirin is the most widely used drug worldwide. Low dose aspirin has been shown to improve outcome in patients with ischemic heart disease, but approximately 12% of these patients will suffer from a vascular event during a 2 year follow-up period despite aspirin therapy. It has been speculated that these patients might be "resistant" to the antiaggregatory effect of aspirin, and a diminished response to aspirin has been correlated with a less favourable outcome. However, at present no international consensus exists on how to measure "aspirin resistance".

Comparisons: The platelet aggregation in patients with ischemic heart disease on chronic, low dose aspirin is compared to platelet aggregation i healthy volunteers evaluated with different tests. The traditional way of evaluating platelet function, Platelet Aggregometry a.m. Born, will be compared to 3 point-of-care tests (VerifyNow, PFA-100 and Multiplate Whole Blood Aggregometer) and to urin- and serum thromboxane metabolites as a measure of COX inhibition.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Drug Resistance
Drug: acetylsalicylic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2007
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Inclusion Criteria:

  • ischemic heart disease verified with a coronary angiogram
  • treatment with 75 mg aspirin once daily

Exclusion Criteria:

  • ischemic vascular event within the previous 12 months
  • percutaneous coronary intervention or coronary artery by-pass grafting within the previous 12 months
  • treatment with NSAID, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drug affecting platelet aggregation
  • platelet count < 120 x 10^9/l
  • not able to give informed consent
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00389129
20060142
No
Not Provided
University of Aarhus
Danish Research Agency
Study Director: Steen D Kristensen, MD, DMSc Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, 8200 Aarhus N, DK - Denmark
Principal Investigator: Erik L Grove, MD Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, 8200 Aarhus N, DK - Denmark
University of Aarhus
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP