Canakinumab for Cardiovascular Disease
(TECTONIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether canakinumab, a drug that reduces inflammation, can benefit individuals with a history of heart disease. The researchers aim to determine if this drug can lower inflammation in blood vessels, particularly in those who have experienced a heart attack or undergone a stent procedure. Participants will receive either canakinumab or a placebo injection every three months, assigned randomly. Suitable candidates include those who had a heart attack or stent procedure more than six months ago and have undergone genetic testing for TET2 CHIP. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as prescription steroids or anti-inflammatory drugs, if you are currently using them. If you have used oral steroids or prescription anti-inflammatory medications for more than 7 days in the past month, or IV/IM steroids in the past 3 months, you may not be eligible to participate.
Is there any evidence suggesting that canakinumab is likely to be safe for humans?
Research has shown that canakinumab is generally safe for people. In earlier studies, those taking canakinumab experienced fewer major heart problems compared to those who took a placebo, a harmless pill. These studies also found that canakinumab can reduce certain signs of inflammation without altering cholesterol levels.
Although some studies did not observe significant changes in blood sugar levels, the treatment remained safe. Participants have not reported any serious side effects that would raise major concerns. This suggests that canakinumab might be a safe option for people with heart disease.12345Why do researchers think this study treatment might be promising for cardiovascular disease?
Unlike the standard treatments for cardiovascular disease, which often include medications like statins and beta-blockers that primarily focus on managing cholesterol and blood pressure, canakinumab acts on inflammation. It targets interleukin-1β, a key player in the inflammatory process linked to cardiovascular risk. Researchers are excited about canakinumab because it represents a novel approach by addressing inflammation directly, which could lead to improved outcomes for patients who do not respond adequately to traditional therapies. This new mechanism of targeting inflammation is what sets canakinumab apart and drives enthusiasm in the medical community.
What evidence suggests that canakinumab might be an effective treatment for cardiovascular disease?
Research has shown that canakinumab, a drug that reduces inflammation, can greatly benefit people with heart disease. In earlier studies, this treatment lowered the risk of major heart-related problems by 25% in some patients. It was especially helpful for those who had previous heart attacks and high levels of inflammation, measured by a blood marker called hsCRP. Canakinumab reduces inflammation, a key factor in heart disease, and decreases a specific protein linked to inflammation without altering cholesterol levels. In this trial, participants will receive either canakinumab or a placebo to further evaluate its potential as a promising option for lowering the risk of heart disease.26789
Are You a Good Fit for This Trial?
This trial is for individuals with a history of coronary artery disease. It's specifically looking at those who may also have clonal hematopoiesis, which can be driven by mutations in the TET2 gene.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment includes coronary CT angiography and SPECT imaging for a subset of participants
Treatment
Participants receive canakinumab or placebo injections every 3 months for 4 doses
Imaging Assessment
Repeat imaging assessments for vascular inflammation
Final Study and Safety Assessments
Participants undergo final study and safety assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Canakinumab
Trial Overview
The study tests if canakinumab, an anti-inflammatory drug targeting IL-1 beta, reduces vascular inflammation compared to a saline placebo in participants with coronary artery disease.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants with and without TET2 CHIP will receive 150mg of canakinumab every 3 months for 4 doses as part of the randomized clinical trial part of this proposal.
Participants with and without TET2 CHIP will receive placebo injection every 3 months for 4 doses as part of the randomized clinical trial part of this proposal.
Canakinumab is already approved in European Union, United States for the following indications:
- Cryopyrin-Associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
- Familial Mediterranean Fever (FMF)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Adult-Onset Still's Disease (AOSD)
- Cryopyrin-Associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
- Familial Mediterranean Fever (FMF)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Adult-Onset Still's Disease (AOSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Broad Institute
Collaborator
Yale University
Collaborator
Broad Institute of MIT and Harvard
Collaborator
Published Research Related to This Trial
Citations
Novartis canakinumab (ACZ885) reduced cardiovascular ...
Subgroup of patients had a 25% reduction in major adverse cardiovascular events when treated with canakinumab in a new analysis of Phase III ...
Canakinumab Anti-Inflammatory Thrombosis Outcomes ...
Among patients with a history of MI and elevated hsCRP, canakinumab was effective at preventing adverse cardiac events over a median of 3.7 years.
Cost-Effectiveness of Canakinumab From a Canadian ...
Canakinumab is a novel monoclonal antibody therapy that has been shown to reduce CV events but is associated with side effects and high cost.
Cost-effectiveness of Canakinumab for Prevention ...
Patients in the CANTOS trial treated with canakinumab, 150 mg, every 3 months had a 15% lower risk of the primary outcome (the composite of ...
Antiinflammatory Therapy with Canakinumab for ...
Canakinumab significantly reduced high-sensitivity C-reactive protein levels from baseline, as compared with placebo, without reducing the LDL ...
Novartis canakinumab (ACZ885) reduced cardiovascular ...
Subgroup of patients had a 25% reduction in major adverse cardiovascular events when treated with canakinumab in a new analysis of Phase III ...
NCT01327846 | Cardiovascular Risk Reduction Study ...
A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events.
Canakinumab and cardiovascular outcomes: results of the ...
The results suggest that anti-inflammatory therapy using canakinumab at a dose of 150 mg every 3 months led to significantly lower recurrent cardiovascular ...
Effects of Interleukin-1β Inhibition With Canakinumab on ...
In this phase IIb randomized trial, monthly doses of canakinumab, a monoclonal antihuman IL-1β antibody, had a modest but nonsignificant effect on HbA1c and ...
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