Atherosclerosis Monitoring and Atherogenicity Reduction Study

Phase 3

Completed

• Conditions: Carotid Atherosclerosis
• Interventions: Drug: Placebo; Dietary Supplement: Allicor

• Registration Number: NCT01734707
• Lead Sponsor: Institute for Atherosclerosis Research, Russia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Status Verified: 2005-01
• Primary Completion: 2005-01
• Study Completion: 2005-10
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-21
• Last Update Submitted: 2012-11-21
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	Placebo tablet 150 mg by mouth two times a day
Allicor	Allicor	Allicor 150 mg tablet by mouth two times a day

Primary Outcome Measures

Name	Time	Method
high-resolution B-mode ultrasonography of common carotid arteries	up to 2 years	Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries

Secondary Outcome Measures

Name	Time	Method
Measure of serum atherogenicity	up to 2 years	Change of the ability of serum to induce cholesterol accumulation in cultured cells

Trial Locations

Locations (1)

Institute for Atherosclerosis Research; 🇷🇺 Moscow, Russian Federation