This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12.
Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female patients, aged ≥ 30 to ≤ 80 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
✓. Spontaneous acute mycardial infarction (AMI) (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis.
✓. Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
✓. Patient with previous MI events in history can be included.
✓. Patient with body weight of ≤ 120 kg.
✓. N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and \< 8000 pg/ml at screening.
✓. Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.
Exclusion criteria
✕. A woman of childbearing potential (WOCBP).
✕. Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
✕. Patient with New York Heart Association (NYHA) class IV at screening or randomization.
✕. Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
✕. Patient has severe valvular heart disease.
✕. Patient has systolic BP \< 90 mmHg or \> 180 mmHg, diastolic BP \< 50 mmHg or \> 110 mmHg, and/or heart rate \< 50 or \> 100 beats/minute at screening or randomization.
✕. Patient with an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or on dialysis.
✕. Patient with hepatic insufficiency classified as Child-Pugh B or C.