Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI

NCT04347434 | Recruiting Phase 4 DMC

• 1 other identifier: PSU/T-471
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In a single-center, open-label, prospective, controlled, clinical study, it is planned to include 300 patients hospitalized in the cardiology department of SBHI Penza regional clinical hospital n.a. N.N. Burdenko. Recruitment of patients will be carried out at the Department of Therapy of the Medical Institute of the Penza State University. Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study. Initially, lipid-lowering treatment with atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy. If there is no achievement of the target level of LDL-C, ≤1.5 mmol / L after 5-6 weeks from the AMI onset, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day. Standard AMI treatment includes dual antiplatelet therapy, ACE inhibitors, beta-blockers (if indicated). Prescription of proton pump inhibitors and nitrates is possible (if indicated). The total follow-up is 96 weeks. Prescreening - 600 people; screening and randomization - 300 people. Parameters of electrical myocardial heterogeneity, myocardial deformation characteristics, vascular rigidity, and quality of life will be assessed according to the study plan.

Conditions

Myocardial Infarction, Acute; Myocardial Strain; Arterial Stiffness; Quality of Life

Keywords

STEMI; NSTEMI; myocardial strain,; arterial stiffness,; lipid-lowering therapy,; electrical myocardial heterogeneity

Outcome Measures

Primary Outcomes (6)

• Ventricular arrhythmias

  Statistically significant differences in the frequency of ventricular arrhythmias as compared to controls

  up to 48 months

• Systolic function

  Statistically significant differences in systolic function of the left ventricle according to transthoracic echocardiography as compared to controls;

  up to 48 months

• Myocardial deformation of the LA and LV

  Statistically significant differences in the myocardial deformation of the LA and LV as compared to controls

  up to 48 months

• PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina

  Statistically significant differences for major coronary events - PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina as compared to controls

  up to 48 months

• Myocardial electrical instability

  Statistically significant differences in the late ventricular potentials, heart rate variability, QT interval dispersion (ms) as compared to controls

  up to 120 hours for 2 years period

• Heart rate turbulence

  Statistically significant differences in the parameters of heart rate turbulence (%) as compared to controls

  up to 120 hours for 2 years period

Secondary Outcomes (15)

• Cardiovascular mortality

  up to 48 months

• Frequency of repeated fatal / non-fatal MI

  up to 48 months

• Hospitalization due to acute decompensation of heart failure

  up to 48 months

• Structural state of arteries different types

  up to 48 months

• Structural state of carotid artery

  up to 48 months

Study Arms (2)

Atorvastatin 80 mg

EXPERIMENTAL

Treatment with atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy. If there is no achievement of the target level of LDL-C, ≤1.5 mmol / L after 5-6 weeks from the AMI onset, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.

Drug: Atorvastatin 80mg

Atorvastatin-Ezetimibe

ACTIVE COMPARATOR

In the absence of reaching the target level of LDL-C of ≤1.4 mmol / L and a decrease in the indicator by ≥50% after 5-6 weeks from the onset of AMI, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.

Drug: Atorvastatin 80mg

Interventions

Atorvastatin 80mg DRUG

Atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy

Also known as: Ezetimibe

Atorvastatin 80 mg; Atorvastatin-Ezetimibe

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Signed Informed Consent Form 2 Primary STEMI or NSTEMI confirmed by ECG, troponin I and CPK-MB levels, coronary angiography.
• \. Presence of an infarct-related artery according to coronary angiography.

You may not qualify if:

• Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
• Recurrent or repeated myocardial infarction.
• Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
• The development of acute heart failure III-IV prior to randomization
• Individual intolerance to statins, ezetimibe.
• Congenital and acquired heart diseases.
• Severe concomitant diseases in the stage of decompensation.
• Non-sinus rhythm, established artificial pacemaker.
• Sinoatrial and atrioventricular blockade of 2-3 degrees.
• QRS complex exceeding 100 ms.
• The presence of severe LV hypertrophy according to echocardiography.
• Uncontrolled hypertension with SBP\> 180 mm Hg and DBP\> 110 mmHg
• Diabetes mellitus (DM) type 1 and 2.
• Current existence of severe anemia (Hb \< 100 g/L)
• Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI).

Sponsors & Collaborators

• Penza State University: lead

Study Sites (1)

Valentin Oleynikov

Penza, 440026, Russia

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

Atorvastatin; Ezetimibe

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; Azetidines; Azetines

Study Officials

• Valentin E Oleynikov, DM

  Penza State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadezhda V Burko, PhD

CONTACT

+78412548229; hopeful.n@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DM

Model Details: Initially, hypolipidemic treatment with atorvastatin at a dose of 80 mg / day is prescribed from the first 24-96 hours of AMI in addition to standard therapy for the disease.

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 15, 2020
• Study Start: February 12, 2020
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)