Influence of Additional Physician's Consultations and Short Message Service (SMS) Reminders to Patient Compliance (3P)

The League of Clinical Research, Russia

Status: Completed

Conditions: Lipid Metabolism Disorders

Treatments: Drug: atorvastatin

Study type: Observational

Funder types: Other

Identifiers

NCT04863274

Primary Prevention Program

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,912 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,912 participants in 1 patient group

Expanded consultation group

Description:

In an expanded consultation group is being conducted in the study group on the importance of primary prevention of cardiovascular diseases and on the reduction of cardiovascular risk by taking statins. Patients are given brochures and information materials on the risk factors for cardiovascular diseases and the possibility of their correction. Also, the patients of the study group are regularly reminded (2 times a month) with the help of SMS mailings and calls of health workers about the need to follow the doctor's recommendations for taking atorvastatin and returning to the medical institution.

Treatment:

Drug: atorvastatin