A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat (QGC001) Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction after Acute Myocardial Infarction

Quantum Genomics0 个研究点目标入组 294 人开始时间: 2019年2月13日最近更新: 2021年10月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Quantum Genomics
入组人数: 294

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Subject must provide signed written informed consent. Important Note: Subject must be willing and able to give informed consent for participation in the study.
•2. Men and women >= 18 years of age at Screening.
•3. Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation =0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1-V6).
•4. Primary PCI of the index-MI-related artery within 24 hours after the MI.
•5. Women of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post-dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depot, patch, or injectable), together with supplementary double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
•6. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit.
•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 147
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 147

排除标准

•1. Body mass index >45 kg/m².
•2. Subject is hemodynamically unstable or has cardiogenic shock.
•3. Subjects with clinical signs of HF (Kilipp III and IV corresponding to severe HF).
•4. Systolic blood pressure <100 mmHg at Inclusion Visit.
•5. Early primary PCI of the index-MI-related artery performed within 3 hours after MI. Important Note: the time of the PCI MUST NOT be delayed because of the protocol; if PCI is performed within 3 hours after MI, the subject is not eligible.
•6. Subjects who require treatment with angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blocker (ARB), or sacubitril/valsartan after the index magnetic resonance imaging. Note: if treatment was for HTN, ACE-I/ARB should be stopped, right before index magnetic resonance imaging, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE-I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE-I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
•7. Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
•8. Subjects with any contraindication related to the CMRI procedure (devices or metal foreign bodies, including pacemaker, defibrillator) including severe claustrophobia according to the lists/safety rules of the local MRI departments.
•9. Female who is breast-feeding, pregnant, or planning to become pregnant during the study.
•10. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
•11. Alkaline phosphatase >3 upper limit of normal (ULN), total bilirubin >/= 1.5 ULN, or direct bilirubin >ULN in subjects with Gilbert’s syndrome at the Screening Visit.
•12. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the Screening Visit.
•13. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia, thalassemia, or sickle cell anemia).
•14. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable >=4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75 x lower limit of normal or >1.5 x ULN.
•15. History of alcohol or drug abuse within the 3 months prior to the Screening Visit that would interfere with study participation or lead to decreased compliance with study procedures or IP intake in the investigator’s opinion.
•16. Participation in another clinical study involving an investigational drug within 30 days prior to Screening, or if a subject plans to participate in another clinical study within 30 days of discontinuation of the IP.
•17. Any condition that in the opinion of the investigator would interfere with study participation, may pose a risk to the subject, or would make study participation not in the best interest of the subject.
•18. Subjects with a life expectancy of less than 1 year per investigator’s discretion.
•19. Any subject who, in the opinion of the investigator, will not be able to follow the protocol.
•The contraindications of Ramipril as given in the summa

研究者

发起方

Quantum Genomics

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