Polyprenols (Ropren) in Acute Coronary Syndrome (POLYNCOR)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: Ropren; Other: Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03122340

Polyprenols

Details and patient eligibility

About

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

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute coronary syndrome
• Informed consent received

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Treatment:

Other: Oil

Polyprenol Group

Experimental group

Description:

Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks

Treatment:

Drug: Ropren