Skip to main content
OpenTrials
Completed

NCT Number: NCT03122340

Polyprenols (Ropren) in Acute Coronary Syndrome

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cardiology Research Institute

Tomsk, 634012, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute coronary syndrome
  • Informed consent received

Exclusion criteria

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

Treatment and study plan

Ropren

Drug

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

Other names: Polyprenol

oil

Other

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

Other names: Placebo

Primary outcomes

  1. Сardiospecific enzymes

    Time frame: At 9 days after acute coronary syndrome

    The levels of CK, CK-MB, Troponin I

  2. Hepatic enzymes

    Time frame: At 2 months after acute coronary syndrome

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

  3. Inflammatory enzymes

    Time frame: At 2 months after acute coronary syndrome

    CRP, Interleukin-6, products of lipid peroxidation

  4. Cognitive Function

    Time frame: At 2 months after acute coronary syndrome

    Cognitive function test evolution: Montreal Cognitive Assessment Scale

  5. Lipid spectrum

    Time frame: At 2 months after acute coronary syndrome

    Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density

  6. Bilirubin

    Time frame: At 2 months after acute coronary syndrome

    Total and direct

  7. Cognitive Function Anxiety

    Time frame: At 2 months after acute coronary syndrome

    Cognitive function test evolution: Sheehan Anxiety Rating Scale

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

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

Acronym: POLYNCOR

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 20, 2017
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.