Atherosclerosis Monitoring and Atherogenicity Reduction Study

Carotid Atherosclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734707
• Other study ID #: IAR-AMAR
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2012
• Last updated: November 21, 2012
• Start date: January 2004
• Est. completion date: October 2005

Study information

• Verified date: January 2005
• Source: Institute for Atherosclerosis Research, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 74 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Dietary Supplement:
• Allicor

Drug:
• Placebo
Sugar pill manufactured to mimic Allicor 150 mg tablet

Locations

Country	Name	City	State
Russian Federation	Institute for Atherosclerosis Research	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Atherosclerosis Research, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high-resolution B-mode ultrasonography of common carotid arteries	Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries	up to 2 years	Yes
Secondary	Measure of serum atherogenicity	Change of the ability of serum to induce cholesterol accumulation in cultured cells	up to 2 years	Yes