Danish Aspirin Resistance Trial - Pilot Study
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| First Received Date ICMJE | October 17, 2006 | ||||||||
| Last Updated Date | December 10, 2007 | ||||||||
| Start Date ICMJE | November 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00389129 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Danish Aspirin Resistance Trial - Pilot Study | ||||||||
| Official Title ICMJE | Comparative Evaluation of Aspirin Resistance With Point-of-Care Testing - Danish Aspirin Resistance Trial (DANART) - Pilot Study | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Drug Resistance | ||||||||
| Intervention ICMJE | Drug: acetylsalicylic acid | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | March 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00389129 | ||||||||
| Other Study ID Numbers ICMJE | 20060142 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||
| Collaborators ICMJE | Danish Research Agency | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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