Primary Prevention Program (3P)

The Program to Assess the Influence of Routing and Extended Statin Counseling of Patient With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance

A systematic collection of retrospective and prospective data based on non-intervention patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases:

• the retrospective part: database of patients with cardiovascular risks;
• the prospective part: observation of patients in the real medical practice

Study Overview

• Status: Completed
• Conditions: Primary Prevention of Cardiovascular Disease
• Intervention / Treatment: Behavioral: extended counseling

Detailed Description

The research program will have two parts:

Stage1: identification of patients with moderate, high and very high cardiovascular risks, not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs.

Stage 2: a prospective observation of patients receiving primary medical prophylaxis of CVD with atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 2912
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Astrakhan, Russian Federation
    • Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention
  • Nizhny Novgorod, Russian Federation
    • Nizhny Novgorod Regional Center for Medical Prevention
  • Novosibirsk, Russian Federation
    • Regional Center for Medical Prevention
  • Samara, Russian Federation
    • Samara Regional Center for Medical Prevention
  • Ufa, Russian Federation
    • Republican Center for Medical Prevention of the Republic of Bashkortostan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Men and women 40-65 years old with the presence of:

• moderate cardiovascular risk (<5% but ≥1% on a SCORE scale) and cholesterol level LDL ≥3.0 mmol / l, in which the target is not reached during the improvement of lifestyle level of cholesterol-LDL, and the attending physician considers appropriate the appointment lipid-lowering drugs (statins), or
• high cardiovascular risk (≥5% but <10% on a SCORE scale) and cholesterol level LDL ≥ 2.5 mmol / l, or
• very high cardiovascular risk (≥10% on the SCORE scale) and cholesterol-LDL ≥1.8mmol / l, or
• atherosclerotic stenosis of the brachiocephalic arteries> 50% in the absence cerebrovascular diseases and the level of cholesterol-LDL ≥1.8 mmol / l, which do not have contraindications to taking statins and not taking drugs of this group in currently.

Exclusion Criteria:

• The presence of the following clinically significant events in anamnesis: myocardial infarction, stroke, myocardial infarction
• The presence of the following diseases at the time of statin administration: ischemic heart disease; heart failure; atherosclerotic disease of peripheral arteries; atherosclerotic stenosis of the brachiocephalic arteries in the presence of cerebrovascular disease; chronic renal failure with creatinine clearance <30 ml / min; liver disease with an increase in AST and ALT levels of more than 3 times, compared to the upper limit of normal; history of muscular or neuromuscular diseases, with elevated CPK; alcoholism, oncological, mental and other severe concomitant diseases; intolerance to statins in anamnesis; use of other lipid-modifying agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: extended statin counseling group; Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders.	Behavioral: extended counseling; Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
No Intervention: convetional statin counseling group; Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months	The primary objective of this study is to assess the influence of routing and extended statin counseling of patients with cardiovascular risk factors on the change in the percentage of patients who achieved target LDL cholesterol level from baseline through 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the effect of routing and extended statin counseling on changes in treatment adherence	The method used to measure adherence included the Morisky Medication Adherence Scale (MMAS - 4). Morisky Medication Adherence Scale is 4- item self-reported scale measuring medication taking behavior. Scores are transformed to a range of 0-4, in which higher scores reflect better adherence	Baseline and Month 12
Change from baseline in lipid levels (mmol/l)	To evaluate the impact of extended statin counseling on change of CVD risk factors (lipid levels) in patients with moderate, high and very high risk. Measurement of lipid levels at baseline and after 3,6,12 months	Baseline, Month 3, Month 6 and Month 12
Change from baseline in blood pressure (mm Hg)	To evaluate the impact of standard and extended counseling on change of CVD risk factors (blood pressure). Measurement of blood pressure (mm Hg) at baseline and after 3,6,12 months	Baseline, Month 3, Month 6 and Month 12
Impact of standard and extended counseling on statin therapy adherence	The method used to measure adherence was KAP test. KAP test is the specially designed questionnaire for this study includes 14 questions, in patients with hyperlipidemia. KAP test summary score is an assessment of patients' knowledge about high cholesterol, their attitude to this problem and the application of this knowledge. Higher scores reflect better indicators of knowledge, attitudes and practices	Baseline and Month 12

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Collaborators: The League of Clinical Research, Russia
• Investigators: Study Director: Oxana M Drapkina, MD, PhD, Director of National Medical Research Center for Preventive Medicine, Moscow

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: adherence; cardiovascular risk; primary prevention; hyperlipidaemia
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 03-01/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No