Primary Prevention Program

NCT ID: NCT03927196

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2912 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2019-08-28

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

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

Conditions

Primary Prevention of Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

extended statin counseling group

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

Group Type: EXPERIMENTAL

extended counseling

Intervention Type: BEHAVIORAL

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

convetional statin counseling group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

extended counseling

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The League of Clinical Research, Russia

OTHER

Sponsor Role: collaborator

National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oxana M Drapkina, MD, PhD

Role: STUDY_DIRECTOR

Director of National Medical Research Center for Preventive Medicine, Moscow

Locations

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

Astrakhan, , Russia

Nizhny Novgorod Regional Center for Medical Prevention

Nizhny Novgorod, , Russia

Regional Center for Medical Prevention

Novosibirsk, , Russia

Samara Regional Center for Medical Prevention

Samara, , Russia

Republican Center for Medical Prevention of the Republic of Bashkortostan

Ufa, , Russia

Countries

Russia

Other Identifiers

03-01/18

Identifier Type: -

Identifier Source: org_study_id