Orticumab for Heart Attack
(FORTIFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the treatment orticumab, a new potential drug, affects inflammation in individuals who have previously had a heart attack and still experience high inflammation in their coronary arteries. Researchers aim to determine if orticumab can improve heart health compared to a placebo after six months. The trial seeks participants who had a heart attack more than six months ago, have stable heart-related treatments, and experience high coronary inflammation. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in heart health.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you must stop taking your current medications, but you should speak to the study doctor before changing any non-study treatments. You must be on a stable cardiovascular treatment regimen as per local guidelines for post-heart attack patients.
Is there any evidence suggesting that orticumab is likely to be safe for humans?
Research has shown that orticumab, a treatment still under investigation, has been tested for safety and effectiveness in individuals with conditions like psoriasis, which are unrelated to heart problems. In those studies, most participants did not experience serious side effects, indicating that orticumab was generally well-tolerated.
Currently, orticumab is undergoing a phase 2 trial for heart conditions, specifically targeting individuals who have had a heart attack. This phase indicates that researchers have already gathered some safety information from earlier studies. However, they are still assessing its effectiveness for heart conditions, and more details will emerge as the study progresses.
Prospective participants should discuss any concerns with the study doctor. The doctor can provide more personalized information about safety and its relevance to individual health.12345Why do researchers think this study treatment might be promising for heart attack?
Researchers are excited about Orticumab for heart attacks because it offers a novel way to address inflammation, a key player in heart damage following an attack. Unlike traditional treatments like beta-blockers and ACE inhibitors, which primarily focus on managing symptoms and reducing strain on the heart, Orticumab targets specific inflammatory pathways, potentially reducing heart tissue damage during recovery. This innovative approach could lead to quicker, more effective healing and improve long-term heart function, making it a promising addition to current heart attack therapies.
What evidence suggests that orticumab might be an effective treatment for heart attack?
Studies have shown that orticumab may help reduce inflammation in the arteries, which is crucial because inflammation can lead to heart attacks. Orticumab targets and reduces specific harmful substances in the blood that cause this inflammation. Early research suggests it might lower the risk of further heart problems in individuals who have already experienced a heart attack. Evidence indicates that reducing this inflammation could improve heart health and decrease the likelihood of future heart issues.12678
Are You a Good Fit for This Trial?
This trial is for adults who had a type-1 heart attack at least 180 days ago, are on stable heart treatment, and have a BMI ≤ 40 kg/m2. They must not have severe angina or recent serious health issues like cancer or substance abuse. Participants need to be able to attend all study visits and follow the protocol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive orticumab or placebo treatment to assess its effects on coronary inflammation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Sub-study
Participants may opt into a Day 14 sub-study for additional safety assessments and biomarker analysis
What Are the Treatments Tested in This Trial?
Interventions
- Orticumab
Trial Overview
The trial tests Orticumab's effect on coronary inflammation in people with past heart attacks, using CCTA imaging. It compares Orticumab with a placebo over six months to see if it reduces inflammation better than no active treatment.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
(\*note to reviewer: company policy does not allow for public disclosure of the exact doses being evaluated because patent applications are currently being filed. We can update this information as soon as it becomes publicly available )
(\*\*note to reviewer: company policy does not allow for public disclosure of the exact doses being evaluated because patent applications are currently being filed. We can update this information as soon as it becomes publicly available )
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abcentra
Lead Sponsor
Citations
Orticumab: the potential to harness oxidized LDL to reduce ...
Elevated FAI has been shown to predict risk of myocardial infarction and cardiac ... The FORTIFY trial will provide important confirmatory evidence of orticumab's ...
NCT06927739 | Focused Orticumab Research for Treating ...
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial ...
Caristo Congratulates Abcentra for First Patient Dosed ...
... Trial Evaluating Orticumab in Patients with Cardiovascular Disease ... myocardial infarction (MI) and elevated coronary inflammation. A ...
Abcentra LLC Announces First Patient Dosed in Phase 2b ...
... Trial Evaluating Orticumab in Patients with Cardiovascular Disease. ... myocardial infarction (MI) and confirmed elevated coronary inflammation.
Orticumab: the potential to harness oxidized LDL to reduce ...
Treatment with orticumab represents a new and plaque-specific way to reduce arterial inflammation ... Purpose of review: Myocardial infarction ...
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clinicaltrials.eu
clinicaltrials.eu/trial/study-of-orticumab-in-adults-with-previous-heart-attack-and-high-coronary-inflammation-measured-by-ct-scan/Study of Orticumab in Adults with Previous Heart Attack ...
The study will test a medication called orticumab, which is given as an injection, to determine its effects on reducing inflammation in the heart's blood ...
NCT04776629 | A Proof-of-Activity Study With Orticumab in ...
The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis ...
Orticumab
Orticumab acts directly at the site of coronary artery inflammation, binding to oxLDL and inhibiting local macrophage activation. This targeted approach may not ...
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