Actively Recruiting
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Led by Penza State University · Updated on 2023-11-24
300
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent Form
- Confirmed primary STEMI or NSTEMI by ECG, troponin I, CPK-MB levels, and coronary angiography
- Presence of an infarct-related artery according to coronary angiography
You will not qualify if you...
- Hemodynamically relevant stenosis exceeding 30% in multiple coronary arteries
- Recurrent or repeated myocardial infarction
- Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia)
- Acute heart failure III-IV before randomization
- Individual intolerance to statins or ezetimibe
- Congenital or acquired heart diseases
- Severe concomitant diseases in decompensation stage
- Non-sinus rhythm or artificial pacemaker
- Sinoatrial or atrioventricular block of 2nd-3rd degree
- QRS complex duration over 100 ms
- Severe left ventricular hypertrophy per echocardiography
- Uncontrolled hypertension (SBP > 180 mm Hg, DBP > 110 mm Hg)
- Diabetes mellitus type 1 or 2
- Severe anemia (hemoglobin < 100 g/L)
- Chronic kidney disease with creatinine clearance < 30 ml/min/1.73 m2
- Untreated thyroid dysfunction
- Body mass index ≥ 35 kg/m2
- Pregnancy or lactation
- Alcohol or drug abuse
- Other serious diseases preventing study participation
- Participation in other clinical trials within last 2 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Valentin Oleynikov
Penza, Russia, 440026
Actively Recruiting
Research Team
N
Nadezhda V Burko, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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