Acute Coronary SyndromePhase 3POLYNCORNCT03122340
Polyprenols (Ropren) in Acute Coronary Syndrome
A Phase 3 study testing Ropren and Oil in people with Acute Coronary Syndrome, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ropren and Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2015to 28 Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome
- Informed consent received
Who cannot join
- Patient's incapacity to take accurately drops by oneself
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ropren, Oil
- Keywords
- Acute Coronary Syndrome, Polyprenols, Cholesterol
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoprenDrug
Also called Polyprenol
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
OilOther
Also called Placebo
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks Receives: 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 Receives: Drug: Ropren |
What is being measured
The primary outcome is the main question the study is designed to answer.
Сardiospecific enzymes
The levels of CK, CK-MB, Troponin I
Measured: At 9 days after acute coronary syndrome
Hepatic enzymes
The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase
Measured: At 2 months after acute coronary syndrome
Inflammatory enzymes
CRP, Interleukin-6, products of lipid peroxidation
Measured: At 2 months after acute coronary syndrome
Cognitive Function
Cognitive function test evolution: Montreal Cognitive Assessment Scale
Measured: At 2 months after acute coronary syndrome
Lipid spectrum
Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density
Measured: At 2 months after acute coronary syndrome
Bilirubin
Total and direct
Measured: At 2 months after acute coronary syndrome
Cognitive Function Anxiety
Cognitive function test evolution: Sheehan Anxiety Rating Scale
Measured: At 2 months after acute coronary syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Nov 2015
- Primary completion31 Dec 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center double-blind, randomized, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgeny V. Vyshlov, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Sergey V Popov, MD, PhD, Study director, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122340
- Sponsor's protocol ID
- Polyprenols
- Acronym
- POLYNCOR
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29998439
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Polyprenols (ROPREN) in Subjects With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03122340
- Acronym / sponsor ID
- POLYNCOR / Polyprenols
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Polyprenols, Cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center double-blind, randomized, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: OilOil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks |
| Polyprenol Group | Experimental | Drug: RoprenPolyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute coronary syndrome
- Informed consent received
Key exclusion criteria (2 listed)
- Patient's incapacity to take accurately drops by oneself
- Cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoprenAlso: PolyprenolPer os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks | Drug | Polyprenol Group |
| OilAlso: PlaceboPer os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks | Other | Placebo Group |
Primary outcome
Сardiospecific enzymes
Time frame: At 9 days after acute coronary syndrome
The levels of CK, CK-MB, Troponin I
Hepatic enzymes
Time frame: At 2 months after acute coronary syndrome
The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase
Inflammatory enzymes
Time frame: At 2 months after acute coronary syndrome
CRP, Interleukin-6, products of lipid peroxidation
Cognitive Function
Time frame: At 2 months after acute coronary syndrome
Cognitive function test evolution: Montreal Cognitive Assessment Scale
Lipid spectrum
Time frame: At 2 months after acute coronary syndrome
Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density
Bilirubin
Time frame: At 2 months after acute coronary syndrome
Total and direct
Cognitive Function Anxiety
Time frame: At 2 months after acute coronary syndrome
Cognitive function test evolution: Sheehan Anxiety Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Derived from this study: PubMed 29998439Vyshlov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey V Popov, MD, PhD study director
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropren and Oil in people with Acute Coronary Syndrome, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Сardiospecific enzymes (time frame: At 9 days after acute coronary syndrome). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.