drugset / Trial / NCT02630862

Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization

NCT02630862

RandomizedParallel-groupSingle-blind

Summary

The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis. Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including vasodilation and antioxidant properties. A role for oxidative stress has been suggested in acute cerebrovascular disease. In this study the investigators want to test the in vivo antioxidant activity of dipyridamole in patients who are candidate to take the drug under approved conditions of the Italian Drug Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis (\>= 70%). To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months therapy after carotid endoarterectomy. Since dipyridamole is approved as combination preparation with aspirin, a control group of patients taking aspirin alone is enrolled. Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points: baseline and 6-months therapy.

Timeline

Start
2010-09
Primary completion
2014-06
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 25 mg Oral
Comparator Aspirin Small molecule 100 mg Oral
Comparator Dipyridamole Other / unclassified 200 mg Oral