Polyprenols (Ropren) in Acute Coronary Syndrome

NCT03122340 — Phase 3, Completed, 70 participants, Tomsk National Research Medical Center of the Russian Academy of Sciences

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

Registry	NCT03122340, acronym POLYNCOR
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	70 (Actual)
Sponsor	Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)
Conditions	Acute Coronary Syndrome
Interventions	Ropren, Oil (Drug, other)
Dates	start 2015-11-01, primary completion 2017-12-31, completion 2018-02-28, first posted 2017-04-20, last updated 2018-04-26
Locations	1 site in Russia

-Summary

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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Placebo Group	Placebo comparator	Other: Oil	Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Polyprenol Group	Experimental	Drug: Ropren	Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Ropren (Drug), also known as Polyprenol: Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Oil (Other), also known as Placebo: Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Acute coronary syndrome
* Informed consent received

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Cardiology Research Institute	Tomsk	Russia

+Publications

Results publication: 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 29998439

+Investigators

Sergey V Popov, MD, PhD, Study director, Tomsk NRMC