Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-70
SponsorPenza State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Atorvastatin 80mg
DrugAtorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Atorvastatin 80 mgExperimental treatment 1 intervention
Group B: Atorvastatin-EzetimibeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ventricular arrhythmias
Statistically significant differences in the frequency of ventricular arrhythmias as compared to controls
Time frame
up to 48 months2
Systolic function
Statistically significant differences in systolic function of the left ventricle according to transthoracic echocardiography as compared to controls;
Time frame
up to 48 months3
Myocardial deformation of the LA and LV
Statistically significant differences in the myocardial deformation of the LA and LV as compared to controls
Time frame
up to 48 months4
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
Time frame
up to 48 monthsSecondary outcomes
1
Cardiovascular mortality
Statistically significant differences for incidence of CV events as compared to controls
Time frame
up to 48 months2
Frequency of repeated fatal / non-fatal MI
Statistically significant differences in the frequency of repeated fatal / non-fatal MI as compared to controls
Time frame
up to 48 months3
Hospitalization due to acute decompensation of heart failure
Statistically significant differences according to the frequency of hospitalization due to acute decompensation of heart failure as compared to controls
Time frame
up to 48 months4
Structural state of arteries different types
Statistically significant differences in pulse wave velocities in arteries of various calibers, as compared to controls
Time frame
up to 48 monthsSponsors and contacts
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Source ClinicalTrials.gov