Clinical trial NCT03927196: Primary Prevention Program
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention of Cardiovascular Disease
Keywords: primary prevention
cardiovascular risk
hyperlipidaemia
adherence
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: The League of Clinical Research, Russia
First posted: 2019-04-25
Enrollment: 2912
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Assess the effect of routing and extended statin counseling on changes in treatment adherence
timeFrame: Baseline and Month 12
measure: Change from baseline in lipid levels (mmol/l)
timeFrame: Baseline, Month 3, Month 6 and Month 12
measure: Change from baseline in blood pressure (mm Hg)
timeFrame: Baseline, Month 3, Month 6 and Month 12
measure: Impact of standard and extended counseling on statin therapy adherence
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Center for Medical Prevention
city: Novosibirsk
country: Russian Federation
facility: Regional Center for Medical Prevention
city: Samara
country: Russian Federation
facility: Samara Regional Center for Medical Prevention
city: Ufa
country: Russian Federation
facility: Republican Center for Medical Prevention of the Republic of Bashkortostan
Study officials:
affiliation: Director of National Medical Research Center for Preventive Medicine, Moscow
name: Oxana M Drapkina, MD, PhD
role: STUDY_DIRECTOR
References: