Assessment of the Effects of Long-term Lipid-lowering Therapy on Parameters of Electrical Myocardial Heterogeneity, Myocardial Deformation Characteristics, Vascular Rigidity, and Quality of Life in Patients With Primary STEMI or NSTEMI

Who is this study for? Patients with Myocardial Infarction
What treatments are being studied? Atorvastatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• 1\. Signed Informed Consent Form 2 Primary STEMI or NSTEMI confirmed by ECG, troponin I and CPK-MB levels, coronary angiography.

• 3\. Presence of an infarct-related artery according to coronary angiography.

Locations
Other Locations
Russian Federation
Valentin Oleynikov
RECRUITING
Penza
Contact Information
Primary
Nadezhda V Burko, PhD
hopeful.n@mail.ru
+78412548229
Time Frame
Start Date: 2020-02-12
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 300
Treatments
Experimental: Atorvastatin 80 mg
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.
Active_comparator: Atorvastatin-Ezetimibe
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.
Related Therapeutic Areas
Sponsors
Leads: Penza State University

This content was sourced from clinicaltrials.gov