Polyprenols (Ropren) in Acute Coronary Syndrome

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

Detailed Description
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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

Official Title
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Single-center Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Polyprenols (ROPREN) in Subjects With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ropren
* Other: Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute coronary syndrome Informed consent received Exclusion Criteria: Patient's incapacity to take accurately drops by oneself Cardiogenic shock

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center double-blind, randomized, placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks | Other: Oil<br>* Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks<br>* Other names: Placebo;|
| Experimental: Polyprenol Group<br>Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks | Drug: Ropren<br>* Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks<br>* Other names: Polyprenol;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Polyprenols, Cholesterol