NCT03122340

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

April 6, 2017

Last Update Submit

April 24, 2018

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary SyndromePolyprenolsCholesterol

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Other: Oil

Polyprenol Group

EXPERIMENTAL

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

Drug: Ropren

Interventions

RoprenDRUG

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

Also known as: Polyprenol
Polyprenol Group
OilOTHER

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

Also known as: Placebo
Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute coronary syndrome
  • Informed consent received

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Research Institute

Tomsk, 634012, Russia

Location

Related Publications (1)

  • 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.

    PMID: 29998439DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

RoprenOils

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

  • Sergey V Popov, MD, PhD

    Tomsk NRMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-center double-blind, randomized, placebo-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 20, 2017

Study Start

November 1, 2015

Primary Completion

December 31, 2017

Study Completion

February 28, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

RU(1)