NCT04347434: CONTRAST-2

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

Recruiting now Phase 4 Last updated 24 November 2023

What this trial tests

Phase 4 trial testing Atorvastatin 80mg in Myocardial Infarction, Acute in 300 participants. Currently enrolling.

Timeline

12 February 2020

Primary endpoint
12 November 2027

30 December 2027

Quick facts

Lead sponsor	Penza State University
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	12 February 2020
Primary completion	12 November 2027
Estimated completion	30 December 2027
Sites	1 location across Russia

Drugs / interventions tested

• Atorvastatin 80mg — full drug profile →

Conditions studied

• Myocardial Infarction, Acute — all drugs for Myocardial Infarction, Acute →
• Myocardial Strain — all drugs for Myocardial Strain →
• Arterial Stiffness — all drugs for Arterial Stiffness →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Penza State University

Who can join

Adults 30 to 70, any sex, with Myocardial Infarction, Acute or Myocardial Strain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Clinical Significance and Potential of Complex Diagnosis for a Large Scar Area Following Myocardial Infarction.
   Oleynikov V, Salyamova L, Alimov N, Donetskaya N, et al · · 2025 · cited 1× · PMID 40647609 · DOI 10.3390/diagnostics15131611
2. Cardiac Magnetic Resonance Imaging Based Ischemic Injury Pattern in Patients with Acute Myocardial Infarction Sensu Left Ventricular Global Systolic Function.
   Salyamova L, Oleynikov V, Donetskaya N, Vdovkin A, et al · · 2024 · PMID 38535009 · DOI 10.3390/diagnostics14060588