Reduced Left Ventricular Ejection Fraction After Myocardial Infarction MedDRA version: 20.0 Level: LLT Classification code 10036233 Term: Post myocardial infarction syndrome System Organ Class: 100000004849
Conditions
Interventions
Product Code: CDR132L
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Not yet defined
Current Sponsor code: CDR132L
Other descriptive name: CDR132L
Concentra
Sponsors
Cardior Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Spontaneous AMI (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis. 3. Patient with a LVEF = 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI). 4. Patient with NSTEMI with evidence of significant myocardial necrosis, evidenced through a troponin T or troponin I increase to at least 5 times the upper limit of normal (ULN) at MI index event diagnosis. 5. Patient with previous MI events in history can be included. 6. A male patient must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period. 7. Patient with body weight of = 120 kg. 8. N-terminal pro B-type natriuretic peptide level = 125 pg/ml and =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: 1.A woman of childbearing potential (WOCBP) as defined in Appendix 5. 2.Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy. 3.Patient with history of decompensated HF or a history of LVEF 180 mmHg, diastolic BP 110 mmHg, and/or heart rate 100 beats/minute at screening or randomization. 8.Patient with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 or on dialysis. 9.Patient with hepatic insufficiency classified as Child Pugh B or C. 10.Patient with known active human immunodeficiency virus, Hepatitis B, or Hepatitis C infection at screening. 11.Impaired hepatic function defined by a total bilirubin level of = 2 × the ULN and ALT levels of = 3 × ULN. 12.Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis. 13.Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/µL). 14.Patient has poorly controlled diabetes as determined by the Investigator. 15.Patient is currently on treatment for epilepsy. 16.Patient has a current or relevant history of physical or psychiatric illness that is/are not stable or may require a change in treatment, use of prohibited therapies during the study, or cause the patient to be unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. 17.Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope. 18.Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients. This will include patients with any of the following (at Screening Visit or Day -1): a)Clinically significant PR (PQ) interval prolongation. b)Intermittent second- or third degree atrioventricular block. c)Sustained cardiac arrhythmia including (but not limited to) supraventricular tachycardia, any symptomatic arrhythmia with the exception of isolated extra systoles. 19.Patient with active “severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” infection confirmed as per the local testing guidelines at screening. 20.Patient has other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the result of the study or the patient's ability to participate in the study. 21.Patient has received an investigational product or treated with an investigational device within 90 days prior to first study drug administration. 22.Patient has known or suspected intolerance or hypersensitivity to the study drug, any closely related compound, or any of the stated ingredients. 23.Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening. a)Treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 2 dose levels (5 and 10 mg/kg) of CDR132L compared with placebo administered in 3 single IV doses given 28 days apart in patients with reduced LVEF = 45% after MI (STEMI or NSTEMI) as add-on therapy to SoC treatment;Secondary Objective: •To assess the safety of 2 dose levels (5 and 10 mg/kg) of CDR132L compared with placebo •To assess the effects of CDR132L compared with placebo on cardiac function •To assess the effects of CDR132L compared with placebo on efficacy related biomarkers •To assess the effects of CDR132L compared with placebo on patient well being;Primary end point(s): Percent change from baseline in LVESVI (screening to occur at least 3 days after MI diagnosis as measured by ECHO [central laboratory]) at Month 6 ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoint 1: Frequency of adverse events and abnormalities in clinical laboratory assessments, vital signs, physical examination, ECGs, and urinalysis Secondary Endpoint 2: Change from baseline LVEF (absolute/relative) at Months 3, 6, and 12. Change from baseline LVESVI at Month 3 (absolute/relative), Month 6 (absolute), and Month 12 (absolute/relative) Secondary Endpoint 3: Change from baseline in absolute/relative troponin T (ng/L) at Months 3, 6, and 12. Change from baseline in absolute/relative values over time for the following efficacy related biomarkers: oN-terminal pro B-type natriuretic peptide (NT-proBNP) Secondary Endpoint 4: • Well-being as evaluated by change from baseline at Months 6 and 12 in the following parameters: oMean KCCQ score and mean scores of subdomains (symptom burden, physical limitation, and quality of life) ;Timepoint(s) of evaluation of this end point: Secondary Endpoint 1: Through out the study Secondary Endpoint 2: 3,6 and 12 months Secondary Endpoint 3: 3,6 and 12 months Secondary Endpoint 4: 6 and 12 months | — |
Countries
Czech Republic, Greece, Hungary, Netherlands, Poland, Spain
Contacts
Public ContactClinical Department
Cardior Pharmaceuticals GmbH
Outcome results
None listed