Primary Prevention Program (3P)

National Research Center for Preventive Medicine

Status

Completed

Conditions

Primary Prevention of Cardiovascular Disease

Treatments

Behavioral: extended counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT03927196

03-01/18

Details and patient eligibility

About

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

Full 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

Enrollment

2,912 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.