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OpenTrials
Completed

NCT Number: NCT04863274

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

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.

Completed

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

League of Clinical Research (LeagueCRR)

Moscow, 119590, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

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.

Other names: SMS and phone call reminders, Patients' consultations

Primary outcomes

  1. Target level of LDL cholesterol

    Time frame: 12 months

    To assess number of patients achieving the target level of low-density lipoprotein cholesterol in study group and in control group.

Sponsors and collaborators

Lead sponsor

The League of Clinical Research, Russia

Other

Collaborators

  • National Research Center for Preventive Medicine

Registry information

Official study 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

Acronym: 3P

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2021
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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