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Immunomodulator

Abatacept for Myocarditis (ATRIUM Trial)

Phase 3
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalized at the time of randomization
Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.

Who is the study for?
Adults hospitalized with myocarditis caused by recent immune checkpoint inhibitor therapy for cancer, who are on or starting high-dose corticosteroids. Participants must have certain blood cell counts within normal ranges, not be pregnant or breastfeeding, and agree to use contraception. Exclusions include active infections like TB, recent live vaccines, other immunosuppressive treatments, and participation in another interventional study.Check my eligibility
What is being tested?
The trial is testing if abatacept can reduce major cardiac events compared to a placebo in patients with myocarditis following cancer treatment with immune checkpoint inhibitors. The main outcome measures include cardiovascular death and various heart-related complications.See study design
What are the potential side effects?
Potential side effects of abatacept may include increased risk of infections due to immune system suppression, possible allergic reactions at the injection site or throughout the body, headache, nausea, and potential worsening of any current infections.

ATRIUM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently in the hospital.
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My heart test shows damage more than 5 times the normal limit recently.
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I have been diagnosed with myocarditis.
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I am not pregnant and agree to use birth control during and 90 days after the study.
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I've had an FDA-approved immune therapy for cancer within the last 6 months.
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I am 18 years old or older.
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I am taking or about to take 1000 mg of solumedrol daily for heart inflammation.
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I agree to use contraception for 90 days after my last dose.

ATRIUM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major adverse cardiac events
Secondary outcome measures
Clinical status at 6 months after first infusion of study drug
Clinical status at 90 days after first infusion of study drug
Fatal and non-fatal DVT and PE
+5 more

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193
67%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept

ATRIUM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abatacept plus standard of careExperimental Treatment1 Intervention
Abatacept (10 mg/kg) will be administered IV after randomization, again at 24 hours after first study drug treatment, at 14 days after first study drug treatment and an optional 4th dose at 28 days.
Group II: Placebo plus standard of carePlacebo Group1 Intervention
Placebo will be administered at the same intervals.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,278 Total Patients Enrolled
1 Trials studying Myocarditis
11 Patients Enrolled for Myocarditis
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,033 Total Patients Enrolled

Media Library

Abatacept (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05335928 — Phase 3
Myocarditis Research Study Groups: Placebo plus standard of care, Abatacept plus standard of care
Myocarditis Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT05335928 — Phase 3
Abatacept (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05335928 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~232 spots leftby Nov 2026