Status:
COMPLETED
Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction
Lead Sponsor:
Cardior Pharmaceuticals GmbH
Conditions:
Myocardial Infarction, Acute
Heart Failure, Left Sided
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
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%...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
- Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
- Patient has medical history of bleeding disorders or has thrombocytopenia (platelets \< 100,000/μL).
- Patient has poorly controlled diabetes as determined by the Investigator.
- 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.
- 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.
- Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
- Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2025
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT05350969
Start Date
July 7 2022
End Date
March 17 2025
Last Update
July 3 2025
Active Locations (49)
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1
Institut klinicke a experimentalni mediciny
Prague, Czechia
2
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
3
St. Marien-Krankenhaus Ahaus
Ahaus, Germany
4
Herzzentrum Dresden Universitätsklinik
Dresden, Germany