The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Atorvastatin Treatment on Carotid Plaque.

NCT00343655

Cardiovascular Diseases

TERMINATED PHASE3

Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin

NCT01785615

Metabolic Syndrome

COMPLETED PHASE1/PHASE2

Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery

NCT00375518

Thoracic Surgery

COMPLETED NA

Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

NCT00300469

Mixed Dyslipidemia Coronary Heart Disease Dyslipidemia

COMPLETED PHASE3

Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

NCT00640549

Hyperlipidemia Diabetes Mellitus, Type 2 Non-Insulin Dependent Diabetes Mellitus

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Symptomatic Carotid Stenosis Hypercholesterolemia Indication for Carotid Endarterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atorvastatin 10 mg/day

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

Group Type ACTIVE_COMPARATOR

Atorvastatin - Cholestyramine - Sitosterol

Intervention Type DRUG

Atorvastatin 80 mg/day

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

Group Type ACTIVE_COMPARATOR

Atorvastatin - Cholestyramine - Sitosterol

Intervention Type DRUG

Cholestyramine - Sitosterol

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

Group Type ACTIVE_COMPARATOR

Atorvastatin - Cholestyramine - Sitosterol

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin - Cholestyramine - Sitosterol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No