Primary Prevention Program

NCT03927196 | Completed

• 1 other identifier: 03-01/18
• Study Type: interventional
• Target: 2,912
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Primary Prevention of Cardiovascular Disease

Keywords

primary prevention; cardiovascular risk; hyperlipidaemia; adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assess the effect of routing and extended statin counseling on changes in treatment adherence

  Baseline and Month 12

• Change from baseline in lipid levels (mmol/l)

  Baseline, Month 3, Month 6 and Month 12

• Change from baseline in blood pressure (mm Hg)

  Baseline, Month 3, Month 6 and Month 12

• Impact of standard and extended counseling on statin therapy adherence

  Baseline and Month 12

Study Arms (2)

extended statin counseling group

EXPERIMENTAL

Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders.

Behavioral: extended counseling

convetional statin counseling group

NO INTERVENTION

Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose

Interventions

extended counseling BEHAVIORAL

Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.

extended statin counseling group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead
• The League of Clinical Research, Russia: collaborator

Study Sites (5)

Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention

Astrakhan, Russia

Location

Nizhny Novgorod Regional Center for Medical Prevention

Nizhny Novgorod, Russia

Location

Regional Center for Medical Prevention

Novosibirsk, Russia

Location

Samara Regional Center for Medical Prevention

Samara, Russia

Location

Republican Center for Medical Prevention of the Republic of Bashkortostan

Ufa, Russia

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Oxana M Drapkina, MD, PhD

  Director of National Medical Research Center for Preventive Medicine, Moscow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: April 25, 2019
• Study Start: June 21, 2018
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)