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

• Sponsor: Institute for Atherosclerosis Research, Russia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01743404
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Atherosclerosis	Dietary Supplement: Inflaminat; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
• Study Start Date: Sep 1, 2007
• Anticipated Primary Completion Date: Feb 1, 2013
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inflaminat Inflaminat 500 mg tablet by mouth three times a day	Dietary Supplement: Inflaminat
Placebo Comparator: Sugar pill Placebo 500 mg tablet by mouth three times a day	Drug: Placebo; Sugar pill manufactured to mimic Inflaminat 500 mg tablet

Outcome Measures

Primary Outcome Measures

1. B-mode ultrasound of carotid arteries [up to 2 years]

   Variation of intima-media thickness of common carotid arteries

Secondary Outcome Measures

1. Measure of serum atherogenicity [up to 2 years]

   Change of the ability of serum to induce cholesterol accumulation in cultured cells

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Atherosclerosis Research	Moscow		Russian Federation

Sponsors and Collaborators

• Institute for Atherosclerosis Research, Russia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute for Atherosclerosis Research, Russia
• ClinicalTrials.gov Identifier: NCT01743404
• Other Study ID Numbers: IAR-INFL
• First Posted: Dec 6, 2012
• Last Update Posted: Dec 6, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Institute for Atherosclerosis Research, Russia: atherosclerosis; inflammation; intima-media thickness
• Additional relevant MeSH terms: Carotid Artery Diseases; Atherosclerosis

Study Results

No Results Posted as of Dec 6, 2012