Randomised Study for Double-blind, Placebo-controlled Evaluation of a Single Intravenous Infusion of BI 765845 and Partially-blinded Evaluation of a Single Bolus Administration of BI 765845 on Top of Standard of Care in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 90
- 主要终点
- Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR)
研究概览
简要总结
This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack.
Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 3 times as likely to receive BI 765845 than placebo.
Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Sponsor team is also masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years (or legal age as per local regulations) at the time of signing informed consent
- •Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
- •Male or female participants of non-childbearing potential. Male participants must be ready and able to use highly effective methods of birth control per ICH M3 (R2) for at least 5 days following investigational medicinl product (IMP) administration. Women who are not of childbearing potential are considered those that fulfil at least one or more of the following: aged 50 years or above and being naturally amenorrhoeic for at least 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential) OR have premature ovarian failure confirmed by a gynaecologist OR have undergone bilateral salpingo-oophorectomy OR have undergone hysterectomy OR are affected by Turner syndrome OR have uterine agenesis
- •Onset of symptoms of myocardial ischaemia or myocardial infarct, according to patient report, within a duration of:
- •Part A: ≥1 hour (h) and ≤12 h prior to randomisation Part B: ≥1 h and ≤12 h prior to randomisation Further inclusion criteria apply.
排除标准
- •Women of childbearing potential
- •Patients indicated for rescue PCI (i.e. after receiving fibrinolysis)
- •Patients presenting with cardiogenic shock defined as either systolic blood pressure (SBP) ≤90 mmHg persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP >90 mmHg.
- •Known history of symptomatic heart failure (HF) with left ventricular systolic dysfunction (i.e. HFrEF) based on verbal medical history as reported by a trial participant or authorised representative
- •Known history of myocardial infarction (MI) with the exception of the index event (based on verbal medical history as reported by a trial participant or authorised representative)
- •Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.
研究组 & 干预措施
BI 765845 high dose group, administration type 2
干预措施: BI 765845 (Drug)
BI 765845 low dose group, administration type 2
干预措施: BI 765845 (Drug)
BI 765845 high dose group, administration type 1
干预措施: BI 765845 (Drug)
BI 765845 very low dose group, administration type 1
干预措施: BI 765845 (Drug)
BI 765845 low dose group, administration type 1
干预措施: BI 765845 (Drug)
Placebo group
干预措施: Placebo matching BI 765845 (Drug)
BI 765845 medium dose group, administration type 1
干预措施: BI 765845 (Drug)
结局指标
主要结局
Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR)
时间窗: At Day 5
次要结局
- Difference in myocardial Infarct size (IS)(At Day 5 and Day 90)
- Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using Late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR)(At Day 90)