Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization
Condition: Carotid Stenosis; Cardiovascular Disease; Atherosclerosis; Stroke
MeSH terms: Carotid Stenosis; Cardiovascular Diseases; Atherosclerosis
Study type: Interventional

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.
    

Detailed description: 
      Dipyridamole has been shown to act as potent antioxidant in vitro. The aim of the present
      study is to analyze if dipyridamole retains the antioxidant in vivo in man.

      The investigators identified a clinical setting where dipyridamole is approved for clinical
      use, i.e. secondary prevention of stroke, to test the hypothesis that dipyridamole given
      orally could affect circulating markers of oxidative stress, in particular reduction in
      oxysterols (autoxidation products of cholesterol) and increase in vitamin E concentration.

      Methods. Two arms are included in the study: a) dipyridamole plus aspirin (in Italy the use
      of dipyridamole is approved in combination with aspirin); b) aspirin alone as comparison arm.
      Patients eligible for endoarterectomy for the presence of carotid stenosis >= 70% are
      randomized in the two arms. The study is open labeled for the patient and clinical
      investigators who have in charge the patinets . The study is blinded for the technicians
      performing biomarker assessment and investigators responsible for data analysis.

      Blood is taken at baseline (before surgery) and after six months of treatment. Oxysterol
      profiling and vitamin E are measured by isotope dilution gas chromatography and mass
      spectrometry.
    

Intervention name(s): Aspirin; aspirin plus dipyridamole
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk; the combination of aspirin plus dipyridamole is approved to lower the risk of stroke in people who have had a transient ischemic attack or stroke
Other intervention name(s): Cardioaspirin, 100 mg; acetylsalicylic acid, 100 mg; aspirin 25 mg plus dipyridamole extended release 200 mg; aggrenox
Intervention MeSH terms: Aspirin; Dipyridamole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: oxidative stress; atherosclerosis; carotid stenosis; oxysterols; vitamin E; lipid peroxidation; antioxidants; aspirin; dipyridamole