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

NCT04347434 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-11-24

No results posted yet for this study

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

Interventions

DRUG

Atorvastatin 80mg

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

Sponsors & Collaborators

  • Penza State University

    lead OTHER

Principal Investigators

  • Valentin E Oleynikov, DM · Penza State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2027-11-12
Completion
2027-12-30

Countries

  • Russia

Study Locations

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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 NCT04347434 on ClinicalTrials.gov