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Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization

NCT02630862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-12-15

No results posted yet for this study

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

Interventions

DRUG

Aspirin

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

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

Sponsors & Collaborators

  • Civic Hospital, Italy

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Giovanni Bertoletti, M.D. · Goretti Hospital, Latina

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630862 on ClinicalTrials.gov