Polyprenols (Ropren) in Acute Coronary Syndrome

Phase 3

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ropren; Other: Oil

• Registration Number: NCT03122340
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome

Detailed Description

This study is randomized double blind placebo controlled. Patients with acute coronary syndrome taking standard therapy including atorvastatin 40 mg/day were randomized into 2 groups: group 1 takes Ropren 8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 take placebo in the same dose regimen. The hepatoprotective, hypolipidemic, antiinflammatory, cognitive, antidepression functions evaluates after one and two - month therapy

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-20
• Primary Completion: 2017-12-31
• Study Completion: 2018-02-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Acute coronary syndrome
• Informed consent received

Exclusion Criteria

• Patient's incapacity to take accurately drops by oneself
• Cardiogenic shock

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyprenol Group	Ropren	Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Placebo Group	Oil	Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Primary Outcome Measures

Name	Time	Method
Сardiospecific enzymes	At 9 days after acute coronary syndrome	The levels of CK, CK-MB, Troponin I
Inflammatory enzymes	At 2 months after acute coronary syndrome	CRP, Interleukin-6, products of lipid peroxidation
Cognitive Function	At 2 months after acute coronary syndrome	Cognitive function test evolution: Montreal Cognitive Assessment Scale
Cognitive Function Anxiety	At 2 months after acute coronary syndrome	Cognitive function test evolution: Sheehan Anxiety Rating Scale
Bilirubin	At 2 months after acute coronary syndrome	Total and direct
Hepatic enzymes	At 2 months after acute coronary syndrome	The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase
Lipid spectrum	At 2 months after acute coronary syndrome	Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density

Trial Locations

Locations (1)

Cardiology Research Institute; 🇷🇺 Tomsk, Russian Federation