Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women (PEARS-POST)

Institute for Atherosclerosis Research, Russia

Status and phase: Completed; Phase 3

Conditions: Atherosclerosis

Treatments: Drug: Placebo; Dietary Supplement: Karinat

Study type: Interventional

Funder types: Other

Identifiers

NCT01742000

IAR-KT-POST

Details and patient eligibility

About

The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.

Enrollment: 180 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women at least 5 years after menopause
• Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
• The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
• The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
• The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion

Exclusion criteria

• Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion

• Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)

• Personal history or diagnostic of following diseases:

  1. Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
  2. Pulmonary thromboembolism
  3. Chronic heart failure IIa-III
  4. Uncontrolled arterial hypertension (systolic blood pressure > 145 mmHg, diastolic blood pressure > 95 mmHg under hypotensive therapy)
  5. Malignancy
  6. Chronic renal failure II-III
  7. Chronic hepatic failure II-III
  8. Liver cirrhosis
  9. Individual intolerance of Karinat or major side effects

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Karinat

Active Comparator group

Description:

Karinat 500 mg tablet by mouth three times a day

Treatment:

Dietary Supplement: Karinat

Sugar pill

Placebo Comparator group

Description:

Placebo 500 mg tablet by mouth three times a day

Treatment:

Drug: Placebo