The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

This study has been completed.
Sponsor:
Collaborators:
Biomedical Foundation for Cardiovascular Research of Padova
Pfizer
Information provided by:
University of Padua
ClinicalTrials.gov Identifier:
NCT01053065
First received: January 20, 2010
Last updated: January 25, 2010
Last verified: January 2005
  Purpose

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.


Condition Intervention
Symptomatic Carotid Stenosis
Hypercholesterolemia
Indication for Carotid Endarterectomy
Drug: Atorvastatin - Cholestyramine - Sitosterol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Resource links provided by NLM:


Further study details as provided by University of Padua:

Primary Outcome Measures:
  • Changes in cellular composition of carotid plaque. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Enrollment: 60
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053065

Locations
Italy
University of Chieti Medical School
Chieti, Italy, 66100
University of Padova Medical School
Padova, Italy, 35128
University of Padova Medical School - Treviso Branch
Treviso, Italy, 31100
Sponsors and Collaborators
University of Padua
Biomedical Foundation for Cardiovascular Research of Padova
Pfizer
Investigators
Principal Investigator: Paolo Pauletto, MD University of Padova - Italy
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01053065     History of Changes
Other Study ID Numbers: MAPS
Study First Received: January 20, 2010
Last Updated: January 25, 2010
Health Authority: Italy: National Institute of Health

Keywords provided by University of Padua:
Atherosclerosis
Macrophages
Carotid arteries
Statin

Additional relevant MeSH terms:
Hypercholesterolemia
Carotid Stenosis
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Cholestyramine Resin
Gamma-sitosterol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014