240 Participants Needed

Orticumab for Heart Attack

(FORTIFY Trial)

Recruiting at 6 trial locations
A
Overseen ByAbcentra
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Abcentra
Must be taking: Statins, PCSK9 inhibitors
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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

I agree to participate in the study and follow all its requirements.
It's been over 6 months since my heart attack, and I haven't had severe chest pain since.
Participant must have body mass index (BMI) ≤ 40 kg/m2
See 3 more

Exclusion Criteria

I am at a higher risk of bleeding.
I haven't had cancer, substance abuse issues, or ongoing infections recently.
Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orticumab or placebo treatment to assess its effects on coronary inflammation

24 weeks
Regular visits for safety assessments and CCTA procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?
4Treatment groups
Active Control
Placebo Group
Group I: Orticumab High DoseActive Control1 Intervention
Group II: Orticumab Low DoseActive Control1 Intervention
Group III: Placebo High DosePlacebo Group1 Intervention
Group IV: Placebo Low DosePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abcentra

Lead Sponsor

Trials
1
Recruited
80+

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.
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40293233/
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 ...
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 ...
OrticumabOrticumab 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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