Clinical trial NCT04863274: Influence of Additional Physician's Consultations and Short Message Service (SMS) Reminders to Patient Compliance
Official title: The Program to Assess the Influence of Routing and In-depth Consultation of Patients With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Metabolism Disorders
Keywords: prevention of cardiovascular diseases
atorvastatin
Lead sponsor: The League of Clinical Research, Russia
Sponsor class: OTHER
Collaborators: name: National Research Center for Preventive Medicine
First posted: 2021-04-28
Enrollment: 2912
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The total population of patients (2912 people) will be divided into three strata:

patients with moderate risk of CVD (1242 patients) patients with high risk of CVD (1044 patients) patients with very high risk of CVD (626 patients). The subjects are randomized to a study or control group in each stratum in the ratio of 1: 1

Brief summary: A systematic collection of retrospective and prospective data based on non-interventional 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 world medical practice.

Detailed description: The research program will have two parts:

Stage 1: identification of patients with moderate, high and very high cardiovascular risk, 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:

Data on the following subjects is planned to be collected in the project:

* Aged from 40 to 65 years inclusively
* With a high (≥5%) cardiovascular risk measured by SCORE and low density lipoprotein (LDL) levels of ≥2,5 mmol/L, or with a very high (≥10%) cardiovascular risk measured by SCORE and LDL levels ≥1,8 mmol/L or With atherosclerotic stenosis of brachiocephalic arteries of \>50% in the absence of cerebrovascular disease

Exclusion criteria:

* No contraindications to statin treatment and not taking stating at study entry.
* History of the following clinically significant events and conditions:

  (а) myocardial infarction (б) stroke (в) transient ischemic attack
* Presence of the following diseases at the time of a statin administration:

  (а) ischemic heart disease (б) heart failure (в) peripheral artery atherosclerosis (г) atherosclerotic stenosis of brachiocephalic arteries with cerebrovascular disease .

Subjects must give their consent for processing of their personal data for the purposes of this scientific project.

Primary outcomes:
measure: Target level of LDL cholesterol
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: League of Clinical Research (LeagueCRR)
Study officials:
affiliation: League of Clinical Research (LeagueCRR)
name: Svetlana I Elkonina, MD
role: STUDY_DIRECTOR
References: