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

NCT02590653 | Completed Phase 4

• 1 other identifier: PSU/T-253
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Myocardial Infarction

Keywords

STEMI; myocardial strain; atorvastatin

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  Myocardial infarction, Unstable angina, Cardiac death

  2 years

Secondary Outcomes (5)

• Global myocardial strain in the zone of previous STEMI and in the intact zone after STEMI

  2 years

• Global myocardial strain rate in the zone of previous STEMI and in the intact zone after STEMI

  2 years

• Intima-media thickness of carotid artery

  2 years

• Carotid-femoral pulse wave velocity

  2 years

• Cardiac-ankle vascular index

  2 years

Study Arms (2)

Group A

EXPERIMENTAL

Group A patients will start atorvastatin at a dose of 80 mg/day between 24 and 96 hours after the onset of STEMI

Drug: Atorvastatin

Group K

ACTIVE COMPARATOR

Group K patients will start atorvastatin at a dose of 20 mg/day between 24 and 96 hours after the onset of STEMI

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Lipid-lowering therapy

Also known as: Statin

Group A; Group K

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Patients having physical and mental ability to participate in the study
• Patients of both sexes aged 35 to 65 years
• Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels.
• Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30%.

You may not qualify if:

• A history of repeat or recurrent myocardial infarction;
• A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA);
• Presence of left ventricular hypertrophy confirmed by echocardiography;
• QRS complex exceeding 1.0;
• Ejection fraction less than 40%;
• Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
• Type 1 diabetes mellitus;
• Type 2 diabetes mellitus requiring pharmacotherapeutic correction with insulin;
• Any severe concurrent disease;
• A history of acute cerebrovascular accident (ACVA) within the 6 month period preceding the study;
• Active hepatic disease or liver enzyme elevation of unclear etiology more than 3 times higher than the upper limit of normal;
• Hepatic failure or bilirubin elevation more than 1.5 times higher than the upper limit of normal;
• Uncontrolled arterial hypertension (AH), with systolic blood pressure (SBP) exceeding 180 mm Hg and diastolic blood pressure (DBP) exceeding 110 mm Hg;
• A history of heart rhythm and/or cardiac conduction disorder;
• Inborn and/or acquired heart defects;

Sponsors & Collaborators

• Penza State University: lead

Study Sites (1)

Valentin Oleynikov

Penza, 440026, Russia

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Valentin Oleynikov, prof.

  Head of Therapy Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

RU (1)