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Abatacept for Myocarditis (ATRIUM Trial)
ATRIUM Trial Summary
This trial will test whether the drug abatacept can reduce major adverse cardiac events in people hospitalized with myocarditis caused by an immune checkpoint inhibitor drug.
ATRIUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowATRIUM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 4 trial • 3 Patients • NCT02078193ATRIUM Trial Design
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Who is running the clinical trial?
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- I am currently in the hospital.My heart test shows damage more than 5 times the normal limit recently.I have been diagnosed with myocarditis.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I am not pregnant and agree to use birth control during and 90 days after the study.I haven't had major heart issues or used specific drugs in the last 2 months.I haven't used specific immune-suppressing drugs in the last 2 months.You are currently taking part in another study using medications to manage immune checkpoint inhibitor-related side effects.I am a male considering fathering a child or donating sperm during or within 30 days after the study.Your recent blood tests show that your white blood cell count, neutrophil count, and liver enzyme levels are within normal ranges.I do not have active or untreated TB or any suspected serious infections.I haven't had a live vaccine in the last 4 weeks and don't plan to during the study.I am 18 years old or older.I do not have any ongoing or frequent viral infections like hepatitis or severe herpes.I've had an FDA-approved immune therapy for cancer within the last 6 months.I am taking or about to take 1000 mg of solumedrol daily for heart inflammation.I agree to use contraception for 90 days after my last dose.
- Group 1: Placebo plus standard of care
- Group 2: Abatacept plus standard of care
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any severe side effects associated with Abatacept?
"Abatacept plus is considered safe by our team at Power. This is a Phase 3 trial, which means that while there is some data supporting efficacy, multiple rounds of data have been collected to support safety."
Are we able to sign new patients up for this experiment yet?
"That is correct. The clinicaltrials.gov website indicates that this trial, which was first announced on June 22nd, is still recruiting patients. There are 390 slots available at the 2 locations where the trial is taking place."
How many individuals are taking part in this research project?
"Yes, as of 8/23/2022 this trial is still recruiting at the 2 locations. A total of 390 patients are needed for the study."
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