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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06139328




Registration number
NCT06139328
Ethics application status
Date submitted
7/11/2023
Date registered
18/11/2023

Titles & IDs
Public title
IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
Scientific title
IRI-EXPLORE: 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
Secondary ID [1] 0 0
U1111-1291-6320
Secondary ID [2] 0 0
1478-0002
Universal Trial Number (UTN)
Trial acronym
IRI-EXPLORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 765845
Treatment: Drugs - Placebo matching BI 765845

Experimental: BI 765845 very low dose group -

Experimental: BI 765845 low dose group -

Experimental: BI 765845 medium dose group -

Experimental: BI 765845 high dose group -

Placebo comparator: Placebo group -


Treatment: Drugs: BI 765845
BI 765845

Treatment: Drugs: Placebo matching BI 765845
Placebo matching BI 765845
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
At Day 5
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
At Day 90
Secondary outcome [2] 0 0
Difference in myocardial Infarct size (IS)
Timepoint [2] 0 0
At Day 5 and Day 90

Eligibility
Key inclusion criteria
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 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
4. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women of childbearing potential
2. 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.
3. Known history of Heart Failure (HF) (based on verbal medical history as reported by a trial participant or authorised representative)
4. 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)
5. Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/03/2027
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
South Western Sydney Local Health District - Liverpool
Recruitment hospital [2] 0 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3076 - Epping
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Dresden
Country [6] 0 0
Germany
State/province [6] 0 0
Frankfurt
Country [7] 0 0
Germany
State/province [7] 0 0
Freiburg
Country [8] 0 0
Germany
State/province [8] 0 0
Hannover
Country [9] 0 0
Germany
State/province [9] 0 0
Langen
Country [10] 0 0
Germany
State/province [10] 0 0
Leipzig
Country [11] 0 0
Germany
State/province [11] 0 0
Ludwigshafen
Country [12] 0 0
Germany
State/province [12] 0 0
Ulm
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Pecs
Country [15] 0 0
Italy
State/province [15] 0 0
Bari
Country [16] 0 0
Italy
State/province [16] 0 0
Caserta
Country [17] 0 0
Italy
State/province [17] 0 0
Catania
Country [18] 0 0
Italy
State/province [18] 0 0
Cona (FE)
Country [19] 0 0
Italy
State/province [19] 0 0
Massa
Country [20] 0 0
Italy
State/province [20] 0 0
Palermo
Country [21] 0 0
Italy
State/province [21] 0 0
Roma
Country [22] 0 0
Italy
State/province [22] 0 0
Torino
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Busan
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Gwangju
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
New Zealand
State/province [26] 0 0
Christchurch
Country [27] 0 0
New Zealand
State/province [27] 0 0
Grafton / Auckland
Country [28] 0 0
Poland
State/province [28] 0 0
Chrzanow
Country [29] 0 0
Poland
State/province [29] 0 0
Myszkow
Country [30] 0 0
Poland
State/province [30] 0 0
Opole
Country [31] 0 0
Poland
State/province [31] 0 0
Rzeszow
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore
Country [33] 0 0
Slovakia
State/province [33] 0 0
Banska Bystrica
Country [34] 0 0
Slovakia
State/province [34] 0 0
Bratislava
Country [35] 0 0
Slovakia
State/province [35] 0 0
Nitra
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Santiago de Compostela
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Spain
State/province [40] 0 0
Vigo
Country [41] 0 0
Taiwan
State/province [41] 0 0
Tainan
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Clydebank
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Leeds
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, 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 in the website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06139328