Danish Aspirin Resistance Trial - Pilot Study

Drug Resistance Clinical Trial

Official title:

Comparative Evaluation of Aspirin Resistance With Point-of-Care Testing - Danish Aspirin Resistance Trial (DANART) - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389129
• Other study ID #: 20060142
• Status: Completed
• Phase: N/A
• First received: October 17, 2006
• Last updated: December 10, 2007
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: December 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Drug Resistance

Intervention

Drug:
• acetylsalicylic acid

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Skejby Sygehus, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Research Agency

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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