Acute Coronary Syndrome
Conditions
Keywords
Acute Coronary Syndrome, Polyprenols, Cholesterol
Brief summary
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
Interventions
DRUGRopren
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
OTHEROil
Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Single-center double-blind, randomized, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute coronary syndrome * Informed consent received
Exclusion criteria
* Patient's incapacity to take accurately drops by oneself * Cardiogenic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Сardiospecific enzymes | At 9 days after acute coronary syndrome | The levels of CK, CK-MB, Troponin I |
| 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 |
Countries
Russia
Outcome results
None listed