Tests long-term cholesterol-lowering treatment after a heart attack
Tests atorvastatin, with ezetimibe if needed, in adults after a heart attack.
Plain-language title generated from the registry record
Registry title: Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Key facts
- Where
- Penza, RussiaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 70 years old?
Source: NCT04347434, who can take part
Where in Russia
- Valentin OleynikovPenza, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Penza State University
- Trial code
- NCT04347434
- Record updated
- 24 November 2023
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: Signed Informed Consent Form 2 Primary STEMI or NSTEMI confirmed by ECG, troponin I and CPK-MB levels, coronary angiography; Presence of an infarct-related artery according to coronary angiography.
Exclusion: The development of acute heart failure III-IV prior to randomization; Severe concomitant diseases in the stage of decompensation; Alcohol abuse, drug addiction; Other serious concomitant diseases that exclude the possibility of study participation; Recurrent or repeated myocardial infarction; Congenital and acquired heart diseases; Uncontrolled hypertension with SBP> 180 mm Hg and DBP> 110 mmHg; Diabetes mellitus (DM) type 1 and 2; Current existence of severe anemia (Hb < 100 g/L); Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI); Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG; Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia); Individual intolerance to statins, ezetimibe; Non-sinus rhythm, established artificial pacemaker; Sinoatrial and atrioventricular blockade of 2-3 degrees; QRS complex exceeding 100 ms; The presence of severe LV hypertrophy according to echocardiography; Non-corrected thyroid dysfunction with hyper / hypothyroidism; Body mass index (BMI) ≥35 kg / m2; Pregnancy, lactation; Participation in other clinical trials within the last two months.