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Completed

NCT Number: NCT02630862

Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization

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.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Disease Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civic Hospital, Vascular Surgery Unit

Latina, LT, 04100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

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

aspirin plus dipyridamole

Drug

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Civic Hospital, Italy

Registry information

Official study title

Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization: Effect of Antithrombotic Treatment

Acronym: ICAR

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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