The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study (MAPS)

April 28, 2021 updated by: University of Padova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients (with Total Cholesterol (TC) ranging between 5.83-7.64 mmol/l), never treated with lipid lowering drugs, with symptomatic carotid stenosis >70% (NASCET criteria), and therefore eligible for carotid endarterectomy, were recruited. All patients were enrolled within 30 days from the clinical event, and randomized to one of three treatment groups. Each group, composed of 20 patients, received atorvastatin 10 mg/day (AT-10 group), or atorvastatin 80 mg/day (AT-80 group), or cholestyramine (Questran, Bristol Myer Squibb) 8 g/day plus sitosterol (Unilever) 2.5 g/day (C-S group) for three months prior to the vascular procedure. A placebo group was not included for ethical reasons due to the high cardiovascular risk profile in this population.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Chieti, Italy, 66100
        • University of Chieti Medical School
      • Padova, Italy, 35128
        • University of Padova Medical School
      • Treviso, Italy, 31100
        • University of Padova Medical School - Treviso Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin 10 mg/day
Arm composed of 20 patients, receiving atorvastatin 10 mg/day
Drug: Atorvastatin - Cholestyramine - Sitosterol
Active Comparator: Atorvastatin 80 mg/day
Arm composed of 20 patients, receiving atorvastatin 80 mg/day
Drug: Atorvastatin - Cholestyramine - Sitosterol
Active Comparator: Cholestyramine - Sitosterol
Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day
Drug: Atorvastatin - Cholestyramine - Sitosterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in cellular composition of carotid plaque.
Time Frame: Three months
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Collaborators

Pfizer
Biomedical Foundation for Cardiovascular Research of Padova

Investigators

  • Principal Investigator: Paolo Pauletto, MD, University of Padova - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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