MedTrace Logo

Assessment of the Effects of Atorvastatin Therapy on Myocardial Deformation Characteristics, in Patients With STEMI

NCT02590653 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-03-24

No results posted yet for this study

Summary

The primary goal

• To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment;

The secondary goals. To evaluate the effect of treatment:

* on the parameters of the global and regional myocardial deformation in the intact area on day 7, on 12, 24, 36 and 48 weeks of treatment;
* on the parameters of the global and regional myocardial deformation depending on the degree of coronary blood flow restoration by thrombolysis in myocardial infarction (TIMI)
* on systolic and diastolic left ventricular function in the presence of initial impairments, or absence of the negative dynamics of these parameters in case of normal baseline values;
* on the clinical diagnostic criteria for the development or progression of heart failure;
* the dynamics of the duration and extent of myocardial ischemia according to the daily ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;
* the appearance of new prognostically significant cardiac arrhythmias
* on the pulse wave velocity
* the thickness of the intima-media complex (IMT); 200 patients are planned to be include in a randomized, single-center, open, prospective, controlled clinical trial, the enrollment will be held at the Department of "Therapy" of Medical Institute of Penza State University.

Definition of the study group:

The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in the study

* Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;
* Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned number of patients: Pre-Screening - 300 subjects; screening and randomization - 200 subjects.

Patients will be randomized by random number generation to include in the group 1 or 2. All included patients will be on the standard basis therapy of the coronary artery disease, according to the national recommendation.

Conditions

Interventions

DRUG

Atorvastatin

Lipid-lowering therapy

Sponsors & Collaborators

  • Penza State University

    lead OTHER

Principal Investigators

  • Valentin Oleynikov, prof. · Head of Therapy Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-12-31
Completion
2020-02-29

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590653 on ClinicalTrials.gov