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Completed

NCT Number: NCT01734707

Atherosclerosis Monitoring and Atherogenicity Reduction Study

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.

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Key information

Conditions

Carotid Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Institute for Atherosclerosis Research

Moscow, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allicor

Dietary Supplement

Other names: time-released garlic powder tablets

Placebo

Drug

Sugar pill manufactured to mimic Allicor 150 mg tablet

Primary outcomes

  1. high-resolution B-mode ultrasonography of common carotid arteries

    Time frame: up to 2 years

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

Secondary outcomes

  1. Measure of serum atherogenicity

    Time frame: up to 2 years

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

Sponsors and collaborators

Lead sponsor

Institute for Atherosclerosis Research, Russia

Other

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 28, 2012
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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