EUCTR2021-006040-27-CZ招募中1 期
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 (HF-REVERT) - HF-REVERT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female of non-childbearing potential 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 < 8000 pg/ml at screening.
- •Note: NT-proBNP values required for eligibility confirmation may be
- •collected at any time post MI either through medical history (e.g., site
- •has collected it as SoC once the patient came to the hospital), through a
- •local laboratory assessment, or by sending a sample to the central
- •laboratory.
- •9. Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention or angiography (if no indication for stent placement or
- •balloon procedure) for this event.
- •10. Capable of giving signed informed consent as described in Appendix 2 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •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 < 30% within 6 months prior to MI index event.
- •4.Patient with NYHA class IV at screening or randomization.
- •5.Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
- •6.Patient has severe valvular heart disease.
- •7.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.
- •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 and clinical-relevant 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 before the first administration of
- •study drug (please see also section 6.5
研究者
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