Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

Institute for Atherosclerosis Research, Russia

Status and phase: Unknown; Phase 2

Conditions: Carotid Atherosclerosis

Treatments: Drug: Placebo; Dietary Supplement: Inflaminat

Study type: Interventional

Funder types: Other

Identifiers

NCT01743404

IAR-INFL

Details and patient eligibility

About

The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.

Enrollment: 300 estimated patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men aged 40 to 70 years
• Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 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 of stroke or transient ischemic attacks
• Chronic diseases demanding drug administration more than during 2 month per year
• Individual intolerance of Inflaminat or appearance of side effects

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Inflaminat

Active Comparator group

Description:

Inflaminat 500 mg tablet by mouth three times a day

Treatment:

Dietary Supplement: Inflaminat

Sugar pill

Placebo Comparator group

Description:

Placebo 500 mg tablet by mouth three times a day

Treatment:

Drug: Placebo