Back to resultsAtherosclerosis Monitoring and Atherogenicity Reduction Study
Primary Purpose
Carotid Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Allicor
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Atherosclerosis focused on measuring atherosclerosis, regression, Allicor, garlic, intima-media thickness
Eligibility 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:
- 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
Sites / Locations
- Institute for Atherosclerosis Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Allicor
Sugar pill
Arm Description
Allicor 150 mg tablet by mouth two times a day
Placebo tablet 150 mg by mouth two times a day
Outcomes
Primary Outcome Measures
high-resolution B-mode ultrasonography of common carotid arteries
Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries
Secondary Outcome Measures
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Full Information
NCT ID
NCT01734707
First Posted
November 16, 2012
Last Updated
November 21, 2012
Sponsor
Institute for Atherosclerosis Research, Russia
1. Study Identification
Unique Protocol Identification Number
NCT01734707
Brief Title
Atherosclerosis Monitoring and Atherogenicity Reduction Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Atherosclerosis Research, Russia
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis
Keywords
atherosclerosis, regression, Allicor, garlic, intima-media thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allicor
Arm Type
Active Comparator
Arm Description
Allicor 150 mg tablet by mouth two times a day
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo tablet 150 mg by mouth two times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Allicor
Other Intervention Name(s)
time-released garlic powder tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill manufactured to mimic Allicor 150 mg tablet
Primary Outcome Measure Information:
Title
high-resolution B-mode ultrasonography of common carotid arteries
Description
Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Measure of serum atherogenicity
Description
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Time Frame
up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
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
Facility Information:
Facility Name
Institute for Atherosclerosis Research
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
20958974
Citation
Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
Results Reference
result
Learn more about this trial
Atherosclerosis Monitoring and Atherogenicity Reduction Study
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