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

Launched by PENZA STATE UNIVERSITY · Apr 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of long-term treatment with cholesterol-lowering medications in patients who have experienced a type of heart attack known as STEMI or NSTEMI. The goal is to see how this treatment affects heart function, blood vessel health, and the overall quality of life for the patients. The study will include 300 patients who are hospitalized and meet specific health criteria, such as having a confirmed heart attack through tests.

Participants in the trial will start treatment with a medication called atorvastatin shortly after their heart attack, and if their cholesterol levels don't reach the target after several weeks, they may also take another medication called ezetimibe. The follow-up period for this study lasts for about 96 weeks, during which the researchers will monitor various heart health indicators. To join the study, patients must provide consent and meet certain conditions, like having a confirmed heart attack, while those with other serious heart problems or certain health conditions may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 1. Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
• • 2. Recurrent or repeated myocardial infarction.
• • 3. Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
• • 4. The development of acute heart failure III-IV prior to randomization
• • 5. Individual intolerance to statins, ezetimibe.
• • 6. Congenital and acquired heart diseases.
• • 7. Severe concomitant diseases in the stage of decompensation.
• • 8. Non-sinus rhythm, established artificial pacemaker.
• • 9. Sinoatrial and atrioventricular blockade of 2-3 degrees.
• • 10. QRS complex exceeding 100 ms.
• • 11. The presence of severe LV hypertrophy according to echocardiography.
• • 12. Uncontrolled hypertension with SBP\> 180 mm Hg and DBP\> 110 mmHg
• • 13. Diabetes mellitus (DM) type 1 and 2.
• • 14. Current existence of severe anemia (Hb \< 100 g/L)
• • 15. Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI).
• • 16. Non-corrected thyroid dysfunction with hyper / hypothyroidism.
• • 17. Body mass index (BMI) ≥35 kg / m2.
• • 18. Pregnancy, lactation.
• • 19. Alcohol abuse, drug addiction.
• • 20. Other serious concomitant diseases that exclude the possibility of study participation.
• • 21. Participation in other clinical trials within the last two months.