The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

NCT01053065

Last updated date
Study Location
University of Chieti Medical School
Chieti, , 66100, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Symptomatic Carotid Stenosis, Hypercholesterolemia, Indication for Carotid Endarterectomy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Symptomatic Carotid Stenosis, Hypercholesterolemia, Indication for Carotid EndarterectomyThe Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
NCT01053065
  1. Chieti,
  2. Padova,
  3. Treviso,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
Official Title  ICMJE The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Symptomatic Carotid Stenosis
  • Hypercholesterolemia
  • Indication for Carotid Endarterectomy
Intervention  ICMJE Drug: Atorvastatin - Cholestyramine - Sitosterol
Study Arms  ICMJE
  • Active Comparator: Atorvastatin 10 mg/day
    Arm composed of 20 patients, receiving atorvastatin 10 mg/day
    Intervention: Drug: Atorvastatin - Cholestyramine - Sitosterol
  • Active Comparator: Atorvastatin 80 mg/day
    Arm composed of 20 patients, receiving atorvastatin 80 mg/day
    Intervention: Drug: Atorvastatin - Cholestyramine - Sitosterol
  • Active Comparator: Cholestyramine - Sitosterol
    Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day
    Intervention: Drug: Atorvastatin - Cholestyramine - Sitosterol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2010)
60
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01053065
Other Study ID Numbers  ICMJE MAPS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE
  • Biomedical Foundation for Cardiovascular Research of Padova
  • Pfizer
Investigators  ICMJE
Principal Investigator:Paolo Pauletto, MDUniversity of Padova - Italy
PRS Account University of Padova
Verification Date January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP