Clinical Trials List
Protocol Number1478-0002
NCT Number(ClinicalTrials.gov Identfier)NCT06139328
2023-09-01 - 2027-07-31
Phase II
Not yet recruiting2
Randomised, Double-blind, Placebo-controlled Study to Investigate a Single 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
2025/08/20
Investigators and Locations
Co-Principal Investigator
- YEN-HUNG LIN 無
- 江君揚 無
- 林柏志 無
- 蔡承烜 無
- CHO-KAI WU 無
- 陳盈憲 無
- 柯宗佑 無
- Chih-Fan Yeh 無
- MAO-HSIN LIN 無
- 黃慶昌 無
- JEN-KUANG LEE 無
- Yi-Chih Wang 無
- 鄭人方 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Myocardial Infarction
Objectives
The primary objectives of this study are, in patients with anterior STEMI scheduled to undergo PCI:
‧ To demonstrate the absolute efficacy of BI 765845 in reducing myocardial IS compared with placebo as measured by cardiac magnetic resonance (CMR) imaging on day 5
‧ Evaluate the safety and tolerability of BI 765845
‧ Characterize the dose-response relationship of BI 765845 in patients with anterior STEMI by evaluating 4 doses and placebo and determine the optimal dose of BI 765845 for use in subsequent Phase III trials
The secondary objectives of this trial are:
‧ Analysis of myocardial IS using day 5 and day 90 CMR measurements
‧ Demonstrate clinical efficacy at day 90 by assessing the measurement of several specific clinical parameters
‧ Demonstrate the safety of BI 765845 before day 90 by assessing the occurrence of serious adverse events (SAE) and drug-related adverse events
Test Drug
BI 765845
Active Ingredient
BI 765845
Dosage Form
Powder for solution for infusion
Dosage
340 mg/vial
Endpoints
Main evaluation indicators:
‧ Measurement of myocardial infarct size as revealed by the detected percentage of left ventricular mass that is infarcted using late gadolinium enhancement (LGE) CMR obtained on day 5
‧ Measurement of myocardial infarct size as revealed by the detected percentage of left ventricular mass that is infarcted using late gadolinium enhancement (LGE) CMR obtained on day 5
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 (either by the patient or impartial witness) 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 medicinal 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: ≥3 h and ≤8 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 (either by the patient or impartial witness) 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 medicinal 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: ≥3 h and ≤8 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 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 Heart Failure (HF) (based on verbal medical history as reported by a trial participant or authorised representative)
Known history of myocardial infarct (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 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 Heart Failure (HF) (based on verbal medical history as reported by a trial participant or authorised representative)
Known history of myocardial infarct (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
