IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
NCT06139328 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-02-04
Summary
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.
Conditions
Interventions
- DRUG
-
BI 765845
BI 765845
- DRUG
-
Placebo matching BI 765845
Placebo matching BI 765845
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-05
- Primary Completion
- 2025-09-02
- Completion
- 2025-12-02
- FDA Drug
- Yes
Countries
- Australia
- Canada
- Czechia
- Germany
- Hungary
- Italy
- New Zealand
- Poland
- Singapore
- Slovakia
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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