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Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization (ICAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02630862
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Civic Hospital, Italy
Information provided by (Responsible Party):
Luigi Iuliano, University of Roma La Sapienza

Brief 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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Cardiovascular Disease Atherosclerosis Stroke Drug: Aspirin Drug: aspirin plus dipyridamole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: aspirin
acetylsalcylic acid 100 mg per day give orally for six months, starting the day of carotid endoartherectomy
Drug: Aspirin
Aspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk
Other Names:
  • Cardioaspirin, 100 mg
  • acetylsalicylic acid, 100 mg

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
Other Names:
  • aspirin 25 mg plus dipyridamole extended release 200 mg
  • aggrenox

Primary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with carotid atherosclerosis eligible for carotid endoarterectomy (stenosis >= 70%) with previous TIA or Stroke

Exclusion Criteria:

  • Congestive heart failure, chronic liver disease, chronic kidney disease (GFR < 60%), cancer, use of antioxidant supplements in the previous 3 months, autoimmune diseases

Information from the National Library of Medicine

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 identifier (NCT number): NCT02630862

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Civic Hospital, Vascular Surgery Unit
Latina, LT, Italy, 04100
Sponsors and Collaborators
University of Roma La Sapienza
Civic Hospital, Italy
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Principal Investigator: Giovanni Bertoletti, M.D. Goretti Hospital, Latina

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Responsible Party: Luigi Iuliano, Associate Professor of Internal Medicine, University of Roma La Sapienza Identifier: NCT02630862    
Other Study ID Numbers: IULIANO_Carotids
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by Luigi Iuliano, University of Roma La Sapienza:
oxidative stress
carotid stenosis
vitamin E
lipid peroxidation
Additional relevant MeSH terms:
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Carotid Stenosis
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents