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BI 765845 in Acute Myocardial Infarction
NCT06139328Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2023
- Primary completion
- Sep 2025
- Countries
- 14
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- BI 765845
- Conditions
- myocardial infarction (MI)
01
Overview
Phase 2, randomised, double-blind trial of BI 765845 in myocardial infarction (MI) (7 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Infarct size measured as the percentage of left ventricular mass that is infarcted at Day 5. Started Dec 2023; status: terminated.
02
Design
7 arms- Study design
- RandomizedDouble-blind
BI 765845 very low dose group, administration type 1
Single administration of very low dose BI 765845 (type 1)
BI 765845 low dose group, administration type 1
Single administration of low dose BI 765845 (type 1)
BI 765845 medium dose group, administration type 1
Single administration of medium dose BI 765845 (type 1)
BI 765845 high dose group, administration type 1
Single administration of high dose BI 765845 (type 1)
Placebo group
Single administration of matching placebo
BI 765845 low dose group, administration type 2
Single administration of low dose BI 765845 (type 2)
1 more in the full profile.
03
Who it enrols
Adults with acute myocardial infarction within 1 to 12 hours of symptom onset, excluding those with cardiogenic shock, history of heart failure, prior myocardial infarction, or previous CABG.
04
Endpoints
Primary
Infarct size measured as the percentage of left ventricular mass that is infarcted
Secondary
Infarct size measured as the percentage of left ventricular mass that is infarcted
Difference in myocardial Infarct size (IS)
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