Atherosclerosis Monitoring and Atherogenicity Reduction Study

This study has been completed.
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia Identifier:
First received: November 16, 2012
Last updated: November 21, 2012
Last verified: January 2005

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 Intervention Phase
Carotid Atherosclerosis
Dietary Supplement: Allicor
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Institute for Atherosclerosis Research, Russia:

Primary Outcome Measures:
  • high-resolution B-mode ultrasonography of common carotid arteries [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries

Secondary Outcome Measures:
  • Measure of serum atherogenicity [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Change of the ability of serum to induce cholesterol accumulation in cultured cells

Enrollment: 300
Study Start Date: January 2004
Study Completion Date: October 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allicor
Allicor 150 mg tablet by mouth two times a day
Dietary Supplement: Allicor
Other Name: 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


Ages Eligible for Study:   40 Years to 74 Years
Genders 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:

    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
  Contacts and Locations
Please refer to this study by its identifier: NCT01734707

Russian Federation
Institute for Atherosclerosis Research
Moscow, Russian Federation
Sponsors and Collaborators
Institute for Atherosclerosis Research, Russia
  More Information

Responsible Party: Institute for Atherosclerosis Research, Russia Identifier: NCT01734707     History of Changes
Other Study ID Numbers: IAR-AMAR
Study First Received: November 16, 2012
Last Updated: November 21, 2012
Health Authority: Russia: Ethics Committee

Keywords provided by Institute for Atherosclerosis Research, Russia:
intima-media thickness

Additional relevant MeSH terms:
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 16, 2014