BI 765845 for Heart Attack

(IRI-EXPLORE Trial)

Not currently recruiting at 140 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 765845, to determine its effectiveness for individuals who have recently experienced a heart attack. The researchers aim to assess the efficacy and safety of different doses for heart attack survivors. Participants will receive either BI 765845 or a placebo, with a higher likelihood of receiving the actual medication. This study suits adults who have experienced heart attack symptoms within the last 12 hours. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BI 765845 is still under investigation to determine its safety and effectiveness for individuals who have experienced a heart attack. A study is currently testing this medicine following initial safety assessments, and early evidence suggests it might be well-tolerated. However, specific information on the frequency of side effects is not yet available.

The study aims to understand how different doses of BI 765845 work and how participants respond to them. The continuation of the study indicates that researchers consider it safe enough for further testing. Participants undergo regular checks for any unwanted effects to ensure their safety. Approval of BI 765845 for this condition will depend on these ongoing safety evaluations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart attack?

Unlike the standard treatments for heart attacks, which typically include medications like beta-blockers, ACE inhibitors, and statins, BI 765845 offers a novel approach. Researchers are excited about BI 765845 because it targets a unique pathway potentially involved in heart attack recovery. This treatment is being explored in various doses and administration methods, which could lead to more personalized and effective care. Its innovative mechanism of action might improve outcomes by addressing the condition differently than existing therapies. Overall, this new avenue holds promise for enhancing patient recovery after a heart attack.

What evidence suggests that this trial's treatments could be effective for heart attack?

Research suggests that BI 765845 could aid individuals who have recently experienced a heart attack. This trial will test various doses and administration methods of BI 765845 to support heart health after such an event. The main goal is to determine if it can improve recovery for heart attack patients. Although the drug remains under investigation, it might enhance heart healing. Early studies are assessing its effectiveness and tolerability. So far, there is hope it might ease recovery for those who have had a heart attack. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 not able to have children and, if male, will use birth control after treatment.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06139328

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps ... 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 ...

2. clinicaltrials.eu clinicaltrials.eu/inn/bi-765845/

BI 765845: A Promising New Drug for Heart Attack Treatment BI 765845 is a new investigational drug being developed to help people who have recently experienced a heart attack, also known as a myocardial infarction.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06139328/iri-explore-a-study-to-test-whether-bi-765845-helps-people-who-have-had-a-heart-attack

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps ... The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack.

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06139328/

Trial | NCT06139328 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 ...

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/bi-765845-boehringer-ingelheim-international-myocardial-infarction-likelihood-of-approval/

BI-765845 by Boehringer Ingelheim International for ... According to GlobalData, Phase II drugs for Myocardial Infarction have a 44% phase transition success rate (PTSR) indication benchmark for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06139328

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps ... 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 ...

7. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/clinical-pipeline/bi-765845-heart-disease-modulator

BI 765845: Heart disease modulator BI 765845: Heart disease modulator. Indication: Myocardial infarction. This compound is under investigation, further information will be available soon.

8. clinicaltrials.eu clinicaltrials.eu/trial/study-to-test-bi-765845-for-patients-with-heart-attack/

Study to Test BI 765845 for Patients with Heart Attack This study investigates the effects and optimal dosage of BI 765845, an infusion-based treatment, for patients recovering from a heart attack or acute ...

9. go.drugbank.com go.drugbank.com/conditions/DBCOND0027900

Myocardial Infarction (DBCOND0027900) IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack ... Cardiovascular Events in Myocardial Infarction Patients - a Safety ...