RecruitingPHASE2INTERVENTIONAL

Focused Orticumab Research for Treating Inflammation in Coronary Arteries

This research, called "Focused Orticumab Research," is testing a new treatment called Orticumab for people who have had a heart attack. The main goal is to find out if Orticumab can reduce inflammation in the arteries of the heart. We know that inflammation can play a role in heart disease. Researchers will use special scans (CCTA) to check this inflammation. Half of the participants will receive Orticumab, and the other half will receive a "dummy" drug (a placebo). They will compare the results after 6 months. This is a Phase 2 trial, meaning it's an earlier stage of testing to see if the drug is effective and safe. Participants will need to attend appointments and keep their study doctors informed about any other treatments they are taking.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Abcentra

Enrolment target

240

Start

11 Aug 2025

Estimated completion

01 Jun 2027

Acute Coronary Syndromes Coronary Arterial Disease (CAD)Inflammation Heart Disease Myocardial Infarct Atherosclerotic Coronary Vascular Disease

What is this study about?

You might be interested in this study if you've had a heart attack and doctors have found inflammation in the blood vessels around your heart. We know that conditions like Acute Coronary Syndromes (which include heart attacks) and Coronary Artery Disease involve inflammation. This study is looking at a new medication called Orticumab to see if it can help reduce this inflammation.

The main aim is to understand if Orticumab can make a difference in the inflammation levels in your heart's arteries. Researchers will use a specific type of scan, called a CCTA, to measure this. They will compare people who take Orticumab with those who take a placebo (a dummy drug with no active ingredients). This comparison helps them see if any changes are due to Orticumab itself and not just other factors.

This is a 'Phase 2' study. This means it's an important step in the research process, where we're looking to see how well the drug works and confirm it's safe for people to use. It helps us learn more about potential new ways to treat heart conditions and improve health after a heart attack.

Key takeaways

Tests a new drug (Orticumab) for heart artery inflammation.
Compares Orticumab to a dummy drug (placebo).
Focuses on people who have previously had a heart attack.
Uses special scans (CCTA) to measure inflammation.
You must already be on stable heart medications.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have had a specific type of heart attack (called a type-1 myocardial infarction) at least 6 months ago, and you shouldn't be experiencing severe chest pain (angina) currently.

It's important that you are already on stable medication for your heart condition, following standard guidelines, which might include drugs for cholesterol, blood thinners, or high blood pressure medicine. Also, scans of your heart's arteries need to show a certain level of inflammation for you to be included. Your Body Mass Index (BMI) should also be 40 or less.

If you are a woman, you must not be pregnant or breastfeeding. You would also need to be past menopause or have had certain surgical procedures that prevent you from becoming pregnant. If you are able to become pregnant, the study would sadly not be suitable.

Quick self-check

Are you 18 years old or older?
Did you have a specific type of heart attack (type-1 MI) at least 6 months ago?
Are you currently on stable medication for your heart condition?
Have heart scans shown a certain level of inflammation in your heart arteries?
Is your Body Mass Index (BMI) 40 or less?
If you are a woman, are you not pregnant or breastfeeding, and either past menopause or unable to become pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll be giving your permission (informed consent) to take part. You'll need to attend all scheduled appointments and provide honest and complete information about your health and medical history. It's really important that you talk to the study doctor before making any changes to your usual medications, starting new ones, getting vaccinations, or joining any other research studies, as this could affect the results.

For some participants, there's an optional extra part of the study happening around Day 14. If you choose to join this, you'll have extra safety checks and a blood sample taken. This blood sample will help researchers measure the level of Orticumab in your body, check for any antibodies your body might make against the drug, and look at other markers related to your heart health and inflammation. The total duration of your participation in the full study will be explained to you by the research team.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks, as Orticumab is an investigational drug, and its full effects, including side effects, are still being studied. You might experience side effects that we don't fully understand yet. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Abcentra Investigational Site
Los Angeles, United States· Not yet recruiting
Abcentra Investigational Site
Torrance, United States· Recruiting
Abcentra Investigational Site
Boca Raton, United States· Recruiting
Abcentra Investigational Site
Richmond, United States· Recruiting
Abcentra Investigational Site
Louisville, United States· Not yet recruiting
Abcentra Investigational Site
Baltimore, United States· Recruiting
Abcentra Investigational Site
Midland, United States· Recruiting
Abcentra Investigational Site
Ostrava, Czechia· Recruiting
Abcentra Investigational Site
Pilsen, Czechia· Recruiting
Abcentra Investigational Site
Prague, Czechia· Recruiting
Abcentra Investigational Site
Prague, Czechia· Recruiting
Abcentra Investigational Site
Brno, Czechia· Recruiting

+29 more sites — see the official record for the full list.

Common questions

What is Orticumab?

Orticumab is the name of the new drug being tested in this study. It's designed to help with inflammation in the heart's arteries.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the study drug but contains no active medicine. It helps researchers see if the real drug is having an effect.

What is CCTA?

CCTA stands for Cardiac Computed Tomography Angiography. It's a special type of X-ray scan that takes detailed pictures of your heart and blood vessels, helping to measure inflammation.

Why is inflammation in the heart important?

Inflammation plays a role in heart conditions like heart attacks and heart disease. Understanding and potentially reducing it could be key to improving heart health.

Can I continue my regular heart medications?

Yes, you must be on stable heart medication as part of the study. However, you should discuss any changes with the study doctor first.

How to find out more

Abcentra

info@abcentra.com 424-369-4401 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.