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

Lipid Metabolism Disorders Clinical Trial

— 3P  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863274
• Other study ID #: Primary Prevention Program
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: October 15, 2020

Study information

• Verified date: April 2021
• Source: The League of Clinical Research, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2912
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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:

(?) myocardial infarction (?) stroke (?) transient ischemic attack

• Presence of the following diseases at the time of a statin administration:

(?) ischemic heart disease (?) heart failure (?) peripheral artery atherosclerosis (?) 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.

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• atorvastatin
Profound patients' consultations (different from standard practice) on the importance of primary prevention of cardiovascular diseases, including preventive administration of statins. Subjects in profound consultation group will receive regular reminders (2 times a month) via SMS and phone calls to check following the doctor's recommendations and remind about follow-up visit to study centre.

Locations

Country	Name	City	State
Russian Federation	League of Clinical Research (LeagueCRR)	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
The League of Clinical Research, Russia	National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target level of LDL cholesterol	To assess number of patients achieving the target level of low-density lipoprotein cholesterol in study group and in control group.	12 months