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Polyprenols (Ropren) in Acute Coronary Syndrome (POLYNCOR)

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Ropren

Oil

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Polyprenols, Cholesterol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Acute coronary syndrome
Informed consent received

Exclusion Criteria:

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

Sites / Locations

Cardiology Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Polyprenol Group

Arm Description

Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Outcomes

Primary Outcome Measures

Сardiospecific enzymes

The levels of CK, CK-MB, Troponin I

Hepatic enzymes

The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase

Inflammatory enzymes

CRP, Interleukin-6, products of lipid peroxidation

Cognitive Function

Cognitive function test evolution: Montreal Cognitive Assessment Scale

Lipid spectrum

Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density

Bilirubin

Total and direct

Cognitive Function Anxiety

Cognitive function test evolution: Sheehan Anxiety Rating Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT03122340

First Posted

April 6, 2017

Last Updated

April 24, 2018

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03122340

Brief Title

Polyprenols (Ropren) in Acute Coronary Syndrome

Acronym

POLYNCOR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

November 1, 2015 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome, Polyprenols, Cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Single-center double-blind, randomized, placebo-controlled study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Arm Title

Polyprenol Group

Arm Type

Experimental

Arm Description

Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Intervention Type

Drug

Intervention Name(s)

Ropren

Other Intervention Name(s)

Polyprenol

Intervention Description

Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Intervention Type

Other

Intervention Name(s)

Oil

Other Intervention Name(s)

Placebo

Intervention Description

Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Primary Outcome Measure Information:

Title

Сardiospecific enzymes

Description

The levels of CK, CK-MB, Troponin I

Time Frame

At 9 days after acute coronary syndrome

Title

Hepatic enzymes

Description

The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase

Time Frame