Polyprenols (Ropren) in Acute Coronary Syndrome

NCT ID: NCT03122340

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2018-02-28

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

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center double-blind, randomized, placebo-controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Group

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

Group Type PLACEBO_COMPARATOR

Oil

Intervention Type OTHER

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

Polyprenol Group

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

Group Type EXPERIMENTAL

Ropren

Intervention Type DRUG

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

Interventions

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Ropren

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

Intervention Type DRUG

Oil

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

Intervention Type OTHER

Other Intervention Names

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Polyprenol Placebo

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Evgeny V. Vyshlov

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergey V Popov, MD, PhD

Role: STUDY_DIRECTOR

Tomsk NRMC

Locations

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Cardiology Research Institute

Tomsk, , Russia

Site Status

Countries

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Russia

References

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Vyshlov EV, Tsoy EI, Sultanov VS, Trusov VB, Ryabov VV. Hypolipidemic and Hepatoprotective Effects of a Polyprenol-Containing Drug in Patients with Acute Coronary Syndrome. Bull Exp Biol Med. 2018 Jul;165(3):319-321. doi: 10.1007/s10517-018-4159-x. Epub 2018 Jul 12.

Reference Type DERIVED
PMID: 29998439 (View on PubMed)

Other Identifiers

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Polyprenols

Identifier Type: -

Identifier Source: org_study_id

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