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Monoclonal Antibodies

BI 765845 for Heart Attack (IRI-EXPLORE Trial)

Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with Left Bundle Branch Block (LBBB)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is looking for adults who have recently had a heart attack to see if a medication called BI 765845 can help them. Participants will be randomly assigned to receive either BI 765845 or

Who is the study for?
Adults over 18 who've just had a heart attack can join this study. They must understand and agree to the trial's process, be unable to have children, and use effective birth control. The trial is not open to those who are pregnant or breastfeeding.
What is being tested?
The study tests BI 765845 against a placebo in heart attack recovery. Participants have a higher chance of receiving BI 765845 than the placebo. Over three months, they'll visit the site seven times and receive calls for health checks on their hearts.
What are the potential side effects?
While specific side effects aren't listed here, participants' health will be monitored for any unwanted effects from either BI 765845 or the placebo during their visits and phone check-ins.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a left bundle branch block in my heart.
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I have had a severe heart condition requiring medication to keep my blood pressure above 90.
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I have a history of heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 765845 very low dose groupExperimental Treatment1 Intervention
Group II: BI 765845 medium dose groupExperimental Treatment1 Intervention
Group III: BI 765845 low dose groupExperimental Treatment1 Intervention
Group IV: BI 765845 high dose groupExperimental Treatment1 Intervention
Group V: Placebo groupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 765845
2023
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,896,945 Total Patients Enrolled
~224 spots leftby Dec 2026
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