Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization (ICAR)
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|ClinicalTrials.gov Identifier: NCT02630862|
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis Cardiovascular Disease Atherosclerosis Stroke||Drug: Aspirin Drug: aspirin plus dipyridamole||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization: Effect of Antithrombotic Treatment|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: aspirin
acetylsalcylic acid 100 mg per day give orally for six months, starting the day of carotid endoartherectomy
Aspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk
Active Comparator: aspirin plus dipyridamole
acetylsalicylic acid 25 mg plus dipyridamole extended release 200 mg, combined in a capsule, per day starting the day of carotid endoartherectomy
Drug: aspirin plus dipyridamole
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
- Level of oxysterol measured by isotope dilution gas chromatography-mass spectrometry [ Time Frame: 6-months ]Oxysterols are used here as markers of oxidative stress, i.e. increased oxidative stress is refected by increased oxysterols levels
- Level of alpha- and gamma-tocopherol (vitamin E isomers) by isotope dilution gas chromatography-mass spectrometry [ Time Frame: 6-months ]Increased oxidative stress is expected to reduce the levels of of vitamin E isomers by consumption
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630862
|Civic Hospital, Vascular Surgery Unit|
|Latina, LT, Italy, 04100|
|Principal Investigator:||Giovanni Bertoletti, M.D.||Goretti Hospital, Latina|