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Atherosclerosis Monitoring and Atherogenicity Reduction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov Identifier:
NCT01734707
First received: November 16, 2012
Last updated: November 21, 2012
Last verified: January 2005
History of Changes
  Purpose

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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01734707

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

Publications:

Responsible Party: Institute for Atherosclerosis Research, Russia
ClinicalTrials.gov 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:
atherosclerosis
regression
Allicor
garlic
intima-media thickness

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013