- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03122340
Polyprenols (Ropren) in Acute Coronary Syndrome (POLYNCOR)
April 24, 2018 updated by: Evgeny V. Vyshlov, Tomsk National Research Medical Center of the Russian Academy of Sciences
Single-center Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Polyprenols (ROPREN) in Subjects With Acute Coronary Syndrome
The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tomsk, Russian Federation, 634012
- Cardiology Research Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute coronary syndrome
- Informed consent received
Exclusion Criteria:
- Patient's incapacity to take accurately drops by oneself
- Cardiogenic shock
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group
Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
|
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Other Names:
|
Experimental: Polyprenol Group
Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
|
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Сardiospecific enzymes
Time Frame: At 9 days after acute coronary syndrome
|
The levels of CK, CK-MB, Troponin I
|
At 9 days after acute coronary syndrome
|
Hepatic enzymes
Time Frame: At 2 months after acute coronary syndrome
|
The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase
|
At 2 months after acute coronary syndrome
|
Inflammatory enzymes
Time Frame: At 2 months after acute coronary syndrome
|
CRP, Interleukin-6, products of lipid peroxidation
|
At 2 months after acute coronary syndrome
|
Cognitive Function
Time Frame: At 2 months after acute coronary syndrome
|
Cognitive function test evolution: Montreal Cognitive Assessment Scale
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At 2 months after acute coronary syndrome
|
Lipid spectrum
Time Frame: At 2 months after acute coronary syndrome
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Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density
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At 2 months after acute coronary syndrome
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Bilirubin
Time Frame: At 2 months after acute coronary syndrome
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Total and direct
|
At 2 months after acute coronary syndrome
|
Cognitive Function Anxiety
Time Frame: At 2 months after acute coronary syndrome
|
Cognitive function test evolution: Sheehan Anxiety Rating Scale
|
At 2 months after acute coronary syndrome
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sergey V Popov, MD, PhD, Tomsk NRMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
April 6, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (Actual)
April 20, 2017
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Polyprenols
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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