A study to test whether BI 765845 helps people who have had a heart attack

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

27 Nov 2023 → 2 Dec 2025

Decision date (initial)

2023-11-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2022-502788-39-00

WHO UTN

U1111-1291-6320

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Efficacy, Therapy, Pharmacokinetic

To assess efficacy of BI 765845 compared with placebo
To assess the safety and tolerability of BI 765845
To characterize the dose-response relationship for BI 765845 in patients with MI by assessing doses and placebo, and to identify the best dose of BI 765845 to be used in the subsequent Phase III trial

Secondary objectives 3

1. To analyse myocardial IS measured using CMR at Day 5 and Day 90
2. To assess clinical efficacy at Day 90 measured by assessing several specific clinical parameters
3. To assess safety until Day 90 assessed by the occurrence of serious adverse events (SAEs) and drug-related adverse events

Conditions and MedDRA coding

acute myocardial infarction

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥18 years (or legal age as per local regulations) at the time of signing informed consent
2. 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
3. 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 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
4. "Onset of symptoms of myocardial ischaemia or myocardial infarct, according to patient report, within a duration of: - Part A: ≥1 h and ≤12 h prior to randomisation - Part B: ≥1 h and ≤12 h prior to randomisation"
5. Further criteria apply.

Exclusion criteria 7

1. Women of childbearing potential
2. Patients indicated for rescue PCI (i.e. after receiving fibrinolysis)
3. Patients presenting with cardiogenic shock defined as either SBP ≤90 mmHg persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP >90 mmHg.
4. Known history of symptomatic HF with left ventricular systolic dysfunction (i.e. HFrEF) based on verbal medical history as reported by a trial participant or authorised representative
5. Known history of MI with the exception of the index event (based on verbal medical history as reported by a trial participant or authorised representative)
6. Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative)
7. Further criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Infarct severity

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Boehringer Ingelheim RCV GmbH & Co. KG

Sponsor organisation

Boehringer Ingelheim RCV GmbH & Co. KG

Address

Dr.-Boehringer-Gasse 5-11, Meidling Meidling

City

Vienna

Postcode

1120

Country

Austria

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

7 EU/EEA countries · 57 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 7 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 152 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

18 submissions — initial application plus substantial / non-substantial modifications