Atherosclerosis Monitoring and Atherogenicity Reduction Study

Institute for Atherosclerosis Research, Russia300 enrolled

Overview

This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Carotid Atherosclerosis

Interventions

AllicorDIETARY_SUPPLEMENT

PlaceboDRUG

Sugar pill manufactured to mimic Allicor 150 mg tablet

Eligibility

Sex: MALEMin age: 40 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men aged 40 to 74 years * Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm) * Arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg) * Absence of chronic diseases demanding permanent drug administration (more than 2 month per year) Exclusion Criteria: * Personal history or diagnostic of following diseases: 1. Transient ischemic attacks 2. Presence of chronic diseases demanding permanent drug administration (more than 2 month per year) 3. Condition of patients moderate to severe * Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system. * Individual intolerance of Allicor or appearance of side effects

Locations (1)

Institute for Atherosclerosis Research

Moscow, Moscow, Russia

Outcomes

Primary Outcomes

high-resolution B-mode ultrasonography of common carotid arteries

Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries

Time frame: up to 2 years

Secondary Outcomes

Measure of serum atherogenicity

Change of the ability of serum to induce cholesterol accumulation in cultured cells

Time frame: up to 2 years

Data from ClinicalTrials.gov

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