Polyprenols (Ropren) in Acute Coronary Syndrome (POLYNCOR)

April 24, 2018 updated by: Evgeny V. Vyshlov, Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute coronary syndrome
  • Informed consent received

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Other: Oil
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Other Names:
  • Placebo
Experimental: Polyprenol Group
Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Drug: Ropren
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Other Names:
  • Polyprenol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Study Director: Sergey V Popov, MD, PhD, Tomsk NRMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Polyprenols

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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