NCT01053065

Brief Summary

The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins. The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
Last Updated

April 30, 2021

Status Verified

January 1, 2005

First QC Date

January 20, 2010

Last Update Submit

April 28, 2021

Conditions

Symptomatic Carotid StenosisHypercholesterolemiaIndication for Carotid Endarterectomy

Keywords

AtherosclerosisMacrophagesCarotid arteriesStatin

Outcome Measures

Primary Outcomes (1)

  • Changes in cellular composition of carotid plaque.

    Three months

Study Arms (3)

Atorvastatin 10 mg/day

ACTIVE COMPARATOR

Arm composed of 20 patients, receiving atorvastatin 10 mg/day

Drug: Atorvastatin - Cholestyramine - Sitosterol

Atorvastatin 80 mg/day

ACTIVE COMPARATOR

Arm composed of 20 patients, receiving atorvastatin 80 mg/day

Drug: Atorvastatin - Cholestyramine - Sitosterol

Cholestyramine - Sitosterol

ACTIVE COMPARATOR

Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day

Drug: Atorvastatin - Cholestyramine - Sitosterol

Interventions

Atorvastatin - Cholestyramine - SitosterolDRUG
Atorvastatin 10 mg/dayAtorvastatin 80 mg/dayCholestyramine - Sitosterol

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic carotid stenosis \> 70% (NASCET criteria)
  • Eligibility for carotid endarterectomy
  • Total cholesterol level between 5.83 and 7.64 mmol/L
  • Never treated with lipid lowering drugs

You may not qualify if:

  • Previous lipid lowering therapy
  • Total cholesterol \<5.83 or \>7.64 mmol/L
  • Evidence of chronic inflammatory disease (clinical and laboratory).
  • Patients at high risk for cerebrovascular events (i.e. ulcerated carotid plaque, recurrent TIAs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Chieti Medical School

Chieti, 66100, Italy

Location

University of Padova Medical School

Padua, 35128, Italy

Location

University of Padova Medical School - Treviso Branch

Treviso, 31100, Italy

Location

Related Publications (2)

  • Pauletto P, Puato M, Faggin E, Santipolo N, Pagliara V, Zoleo M, Deriu GP, Grego F, Plebani M, Sartore S, Bon GB, Heymes C, Samuel JL, Pessina AC. Specific cellular features of atheroma associated with development of neointima after carotid endarterectomy: the carotid atherosclerosis and restenosis study. Circulation. 2000 Aug 15;102(7):771-8. doi: 10.1161/01.cir.102.7.771.

    PMID: 10942746BACKGROUND

  • Faggin E, Zambon A, Puato M, Deeb SS, Bertocco S, Sartore S, Crepaldi G, Pessina AC, Pauletto P. Association between the --514 C-->T polymorphism of the hepatic lipase gene promoter and unstable carotid plaque in patients with severe carotid artery stenosis. J Am Coll Cardiol. 2002 Sep 18;40(6):1059-66. doi: 10.1016/s0735-1097(02)02116-2.

    PMID: 12354428BACKGROUND

MeSH Terms

Conditions

HypercholesterolemiaAtherosclerosis

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paolo Pauletto, MD

    University of Padova - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 21, 2010

Last Updated

April 30, 2021

Record last verified: 2005-01

Locations

IT(3)