Clinical trial NCT05350969: Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction
Official title: 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 (≤ 45%) After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction, Acute
Heart Failure, Left Sided
Lead sponsor: Cardior Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 294
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%) 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.


Eligibility criteria: Main 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 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.
3. Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
4. Patient with previous MI events in history can be included.
5. Patient with body weight of ≤ 120 kg.
6. N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and \< 8000 pg/ml at screening.
7. Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.

Exclusion Criteria:

1. A woman of childbearing potential (WOCBP).
2. Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
3. Patient with New York Heart Association (NYHA) class IV at screening or randomization.
4. Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
5. Patient has severe valvular heart disease.
6. 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.
7. Patient with an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or on dialysis.
8. Patient with hepatic insufficiency classified as Child-Pugh B or C.
9. Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
10. Patient has medical history of bleeding disorders or has thrombocytopenia (platelets \< 100,000/μL).
11. Patient has poorly controlled diabetes as determined by the Investigator.
12. 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.
13. 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.
14. Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
15. Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.

Primary outcomes:
measure: Echocardiography (ECHO)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Institut klinicke a experimentalni mediciny
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Ahaus
country: Germany
facility: St. Marien-Krankenhaus Ahaus
city: Dresden
country: Germany
facility: Herzzentrum Dresden Universitätsklinik
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen GmbH
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Athens
country: Greece
facility: "Alexandra" General Hospital of Athens
city: Athen
country: Greece
facility: "Attikon" General University Hospital
city: Patra
country: Greece
facility: General University Hospital of Patras "Panagia i Voitheia"
city: Budapest
country: Hungary
facility: Semmelweis University
city: Gyula
country: Hungary
facility: BMKK Pándy Kálmán
city: Hatvan
country: Hungary
facility: BKS Research Ltd.
city: Kaposvár
country: Hungary
facility: Somogy County Kaposi Mór Teaching Hospital
city: Nyíregyháza
country: Hungary
facility: Medifarma-98 KFT
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Ede
country: Netherlands
facility: Gelderse Vallei Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Lelystad
country: Netherlands
facility: St. Jansdal Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Sneek
country: Netherlands
facility: D & A Research B.V.
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
city: Kielce
country: Poland
facility: Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Kędzierzyn-Koźle
country: Poland
facility: Polsko Amerykanskie Kliniki Serca
city: Libiąż
country: Poland
facility: Gabinet Internistyczno-Kardiologiczny Jacek Nowak
city: Lublin
country: Poland
facility: One wojskowy Szpital Kliniczny w Lublinie
city: Oświęcim
country: Poland
facility: Medicome Sp. z o.o.
city: Przemyśl
country: Poland
facility: Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu
city: Sopot
country: Poland
facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
city: Toruń
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Wałbrzych
country: Poland
facility: Spec.Szpital im.dr Sokolowskiego
city: Wrocław
country: Poland
facility: Investigational Site
city: Łódź
country: Poland
facility: NZOZ SALUS JZ Peruga
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Sabadell
country: Spain
facility: Hospital Universitario de Sabadell
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: High Wycombe
country: United Kingdom
facility: Wycombe Hospital
city: London
country: United Kingdom
facility: Richmond Pharmacology Limited
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospital NHS Foundation Trust
Study officials:
affiliation: Hannover Medical School
name: Johann Bauersachs, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: