Atherosclerosis Monitoring and Atherogenicity Reduction Study

Sponsor

Institute for Atherosclerosis Research, Russia (Other)

Overall Status

Completed

CT.gov ID

NCT01734707

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Atherosclerosis	Dietary Supplement: Allicor Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Allicor Allicor 150 mg tablet by mouth two times a day	Dietary Supplement: Allicor Other Names: time-released garlic powder tablets
Placebo Comparator: Sugar pill Placebo tablet 150 mg by mouth two times a day	Drug: Placebo Sugar pill manufactured to mimic Allicor 150 mg tablet

Arm

Intervention/Treatment

Active Comparator: Allicor

Allicor 150 mg tablet by mouth two times a day

Dietary Supplement: Allicor

Other Names:

time-released garlic powder tablets

Placebo Comparator: Sugar pill

Placebo tablet 150 mg by mouth two times a day

Drug: Placebo

Sugar pill manufactured to mimic Allicor 150 mg tablet

Outcome Measures

Primary Outcome Measures

high-resolution B-mode ultrasonography of common carotid arteries [up to 2 years]
Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries

Secondary Outcome Measures

Measure of serum atherogenicity [up to 2 years]
Change of the ability of serum to induce cholesterol accumulation in cultured cells

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 74 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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:

Transient ischemic attacks
Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
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