BI 765845 for Heart Attack

(IRI-EXPLORE Trial)

Recruiting at 96 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Disqualifiers: Women childbearing, Rescue PCI, Cardiogenic shock, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 3 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial staff or your doctor.

Eligibility Criteria

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.

Inclusion Criteria

I have signed and understand the consent form for this trial.

I experienced heart attack symptoms between 1 to 12 hours before joining the study.

I am at least 18 years old or of legal age in my country.

Exclusion Criteria

I have a left bundle branch block in my heart.

I have had a severe heart condition requiring medication to keep my blood pressure above 90.

I have a history of heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BI 765845 or placebo for 3 months, with regular health checks and clinical tests to monitor heart health

12 weeks

7 visits (in-person), 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 765845

Trial Overview 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.

Participant Groups

Group I: BI 765845 very low dose group, administration type 1 Experimental Treatment 1 Intervention

Group II: BI 765845 medium dose group, administration type 1 Experimental Treatment 1 Intervention

Group III: BI 765845 low dose group, administration type 2 Experimental Treatment 1 Intervention

Group IV: BI 765845 low dose group, administration type 1 Experimental Treatment 1 Intervention

Group V: BI 765845 high dose group, administration type 2 Experimental Treatment 1 Intervention

Group VI: BI 765845 high dose group, administration type 1 Experimental Treatment 1 Intervention

Group VII: Placebo group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+