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

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ClinicalTrials.gov Identifier: NCT01053065
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : April 30, 2021
Sponsor:
Collaborators:
Biomedical Foundation for Cardiovascular Research of Padova
Pfizer
Information provided by:
University of Padova

Study Description
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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.


Condition or disease Intervention/treatment Phase
Symptomatic Carotid Stenosis Hypercholesterolemia Indication for Carotid Endarterectomy Drug: Atorvastatin - Cholestyramine - Sitosterol Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in cellular composition of carotid plaque. [ Time Frame: Three months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053065


Locations
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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 Padova
Biomedical Foundation for Cardiovascular Research of Padova
Pfizer
Investigators
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Principal Investigator: Paolo Pauletto, MD University of Padova - Italy
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT01053065    
Other Study ID Numbers: MAPS
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: January 2005
Keywords provided by University of Padova:
Atherosclerosis
Macrophages
Carotid arteries
Statin
Additional relevant MeSH terms:
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Carotid Stenosis
Hypercholesterolemia
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
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors