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Monoclonal Antibodies

BI 765845 low dose group 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 5 and day 90

Awards & highlights

IRI-EXPLORE Trial 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.Check my eligibility

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.See study design

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.

IRI-EXPLORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 5 and day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 5 and day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 5 and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Secondary outcome measures

Difference in myocardial Infarct size (IS)

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)

IRI-EXPLORE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,557 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple sites conducting this research within the city?

"Potential participants have the option to enroll at various institutions such as Independent Public Health Care Center of the Ministry of the Interior in Rzeszow, Asklepios Klinik Langen-Seligenstadt GmbH in Langen, and Cardiocenter Nitra, s.r.o in Nitra among 13 additional sites."

Answered by AI

What is the aggregate count of individuals currently enrolled in this clinical investigation?

"Affirmative, the details provided on clinicaltrials.gov affirm that this research endeavor is actively in pursuit of suitable candidates. Originally shared on November 24th, 2023, and last revised by authorities on February 19th, 2024; the trial aims to enlist a total of 350 participants from an assortment of 16 distinct locations."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Yes, information available on clinicaltrials.gov confirms that recruitment for this medical study is ongoing. The trial was first listed on November 24th, 2023 and last revised on February 19th, 2024. It aims to enroll a total of 350 individuals from across 16 different locations."

Answered by AI