Clinical Trials List
Protocol Number1478-0002
NCT Number(ClinicalTrials.gov Identfier)NCT06139328
Active
2023-09-01 - 2027-07-31
Phase II
Recruiting2
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
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Trial Applicant
Boehringer Ingelheim
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 江君揚 Division of General Internal Medicine
- 孟士瑋 Division of General Internal Medicine
- 柯宗佑 Division of General Internal Medicine
- 陳盈憲 Division of General Internal Medicine
- 鄭人方 無
- Yi-Chih Wang Division of General Internal Medicine
- JEN-KUANG LEE Division of General Internal Medicine
- MAO-HSIN LIN Division of General Internal Medicine
- WEI-TIEN CHANG Division of General Internal Medicine
- 蔡承烜 Division of General Internal Medicine
- WenJeng Lee Division of General Internal Medicine
- 林柏志 Division of General Internal Medicine
- Chih-Fan Yeh Division of General Internal Medicine
- CHO-KAI WU Division of General Internal Medicine
- YEN-HUNG LIN Division of General Internal Medicine
- 洪啟盛 Division of General Internal Medicine
- 黃慶昌 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ping-Yen Liu
Co-Principal Investigator
- Po-Tseng Lee Division of Cardiovascular Diseases
- 張獻元 Division of Cardiovascular Diseases
- 黃睦翔 Division of Cardiovascular Diseases
- Yen-Wen Liu Division of Cardiovascular Diseases
- 李見賢 Division of Cardiovascular Diseases
- 胡展瀚 Division of Cardiovascular Diseases
- 陳柏偉 Division of Cardiovascular Diseases
- 廖瑀 Division of Cardiovascular Diseases
- 李文煌 Division of Cardiovascular Diseases
- 柯呈諭 Division of Cardiovascular Diseases
- 陳則瑋 Division of Cardiovascular Diseases
- 葉建寬 Division of Cardiovascular Diseases
- 林佳淩 Division of Cardiovascular Diseases
- 連思涵 Division of Cardiovascular Diseases
- 黃鼎鈞 Division of Cardiovascular Diseases
- 鄭朝允 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Myocardial Infarction
Objectives
The primary objective of this study was to:
• Demonstrate the absolute reduction of myocardial ischemia-ischemia (IS) in patients with anterior wall STEMI scheduled for PCI, using cardiac magnetic resonance (CMR) imaging measurements on day 5, compared to placebo.
• Assess the safety and tolerability of BI 765845.
• Characterize the dose-response and exposure-response relationship of BI 765845 in patients with anterior wall STEMI by evaluating six dose groups and placebo, and determine the optimal dose of BI 765845 for subsequent Phase III trials.
Secondary objectives of this study were:
• Analyze myocardial IS using CMR measurements on days 5 and 90.
• Demonstrate clinical efficacy at day 90 by assessing several specific clinical parameters.
• Demonstrate the efficacy of BI 765845 at day 90 by assessing the occurrence of serious adverse events (SAEs) and drug-related adverse events. Security before the day
Test Drug
注射用凍晶粉末
Active Ingredient
BI 765845
Dosage Form
048
Dosage
340 mg/vial
Endpoints
Key performance indicators:
• CMR obtained on day 5 with late gadolinium enhancement (LGE), measuring the size of the myocardial infarction as indicated by the percentage of the detected left ventricular mass affected by the infarction.
• CMR obtained on day 5 with late gadolinium enhancement (LGE), measuring the size of the myocardial infarction as indicated by the percentage of the detected left ventricular mass affected by the infarction.
Inclution Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria
Exclusion Criteria:
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.
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.
The Estimated Number of Participants
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Taiwan
4 participants
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Global
350 participants
