Atherosclerosis Monitoring and Atherogenicity Reduction Study

Institute for Atherosclerosis Research, Russia

Status and phase: Completed; Phase 3

Conditions: Carotid Atherosclerosis

Treatments: Drug: Placebo; Dietary Supplement: Allicor

Study type: Interventional

Funder types: Other

Identifiers

NCT01734707

IAR-AMAR

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Male

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Allicor

Active Comparator group

Description:

Allicor 150 mg tablet by mouth two times a day

Treatment:

Dietary Supplement: Allicor

Sugar pill

Placebo Comparator group

Description:

Placebo tablet 150 mg by mouth two times a day

Treatment:

Drug: Placebo