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The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks |
|
| Polyprenol Group | Experimental | Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropren | Drug | Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey V Popov, MD, PhD | Tomsk NRMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Research Institute | Tomsk | 634012 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29998439 | Derived | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000621159 | Ropren |
| D009821 | Oils |
| ID | Term |
|---|---|
| D008055 | Lipids |
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Single-center double-blind, randomized, placebo-controlled study
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| Oil | Other | Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks |
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