A Phase 4 interventional study of Aspirin in Intermittent Claudication, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-28.
Sponsored by Aalborg University Hospital · Phase 4, Interventional, and Diagnostic
263 patients with peripheral atherosclerosis were examined to evaluate the activity of the platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg of clopidogrel 2 h before platelet reactivity analysis.
The main hypothesis is that high platelet activity at the beginning of the study is associated with a higher risk of atherothrombosis. Follow up time is 5 years.
Patients with peripheral atherosclerosis are at high risk of atherothrombosis, mainly heart attack and stroke. The medical treatment of these patients include platelet inhibiting drugs, usually aspirin, to reduce the risk of ischemic events. Clopidogrel is another platelet inhibiting drug, which is prescribed less often, primarily because of the high costs compared to aspirin.
Phenomena of 'resistance' to these drugs have been described by numerous investigators. Essentially resistance means that the effect of the drug described is less than expected or missing, as measured by various laboratory methods. We do not know which way resistance is best described, but it has been described that patients who are 'resistant' to either drug are less protected against future heart attacks or strokes.
Main objectives:
Methods:
Platelet activity is measured by the PFA-100 (Dade Behring) and by traditional turbidimetric aggregation.
Endpoints:
Myocardial infarction, unstable angina, cerebral infarction, transitory cerebral ischaemia, sudden deterioration of symptoms, percutaneous or surgical vascular intervention, amputation, death.
254 studies on the registry are indexed under Intermittent Claudication; 45 are open to participants now.
This study's enrollment of 263 is above the median of 70 across 199 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants get Aspirin, and platelet reactivity measurements are performed.
Drug: Aspirin
The effect of Aspirin on platelet function was assessed.
Myocardial infarction, Unstable angina, Cerebral infarction, Transitory cerebral ischaemia, Percutaneous or surgical vascular intervention, Sudden deterioration of symptoms, Amputation, Death.
Time frame: 5 years
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Aalborg University Hospital