Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization

NCT02630862 | Completed DMC

• 1 other identifier: IULIANO_Carotids
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis; Cardiovascular Disease; Atherosclerosis; Stroke

Keywords

oxidative stress; atherosclerosis; carotid stenosis; oxysterols; vitamin E; lipid peroxidation; antioxidants; aspirin; dipyridamole

Outcome Measures

Primary Outcomes (2)

• Level of oxysterol measured by isotope dilution gas chromatography-mass spectrometry

  Oxysterols are used here as markers of oxidative stress, i.e. increased oxidative stress is refected by increased oxysterols levels

  6-months

• Level of alpha- and gamma-tocopherol (vitamin E isomers) by isotope dilution gas chromatography-mass spectrometry

  Increased oxidative stress is expected to reduce the levels of of vitamin E isomers by consumption

  6-months

Study Arms (2)

aspirin

ACTIVE COMPARATOR

acetylsalcylic acid 100 mg per day give orally for six months, starting the day of carotid endoartherectomy

Drug: Aspirin

aspirin plus dipyridamole

ACTIVE COMPARATOR

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

Interventions

Aspirin DRUG

Aspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk

Also known as: Cardioaspirin, 100 mg, acetylsalicylic acid, 100 mg

aspirin

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

Also known as: aspirin 25 mg plus dipyridamole extended release 200 mg, aggrenox

aspirin plus dipyridamole

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Civic Hospital, Italy: collaborator

Study Sites (1)

Civic Hospital, Vascular Surgery Unit

Latina, LT, 04100, Italy

Location

MeSH Terms

Conditions

Carotid Stenosis; Cardiovascular Diseases; Atherosclerosis; Stroke

Interventions

Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Arteriosclerosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Giovanni Bertoletti, M.D.

  Goretti Hospital, Latina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: December 15, 2015
• Study Start: September 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

IT (1)