Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Danish Aspirin Resistance Trial - Pilot Study

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: NCT00389129
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : December 12, 2007
Sponsor:
Collaborator:
Danish Research Agency
Information provided by:
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Drug Resistance Drug: acetylsalicylic acid Not Applicable

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparative Evaluation of Aspirin Resistance With Point-of-Care Testing - Danish Aspirin Resistance Trial (DANART) - Pilot Study
Study Start Date : November 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389129


Locations
Layout table for location information
Denmark
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Danish Research Agency
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00389129    
Other Study ID Numbers: 20060142
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: December 12, 2007
Last Verified: December 2007
Keywords provided by University of Aarhus:
Platelets
Aspirin Resistance
Platelet aggregation
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics