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Antiarrhythmic

Minocycline + Amiodarone for Atrial Fibrillation (MINA Trial)

Phase 2

Waitlist Available

Led By Abdallah k Alameddine, MD

Research Sponsored by Baystate Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All non-congenital cardiac operations are included: CABG, valve repair/replacement, or combination of CABG and heart valve operations

Patients who have undergone non-congenital cardiac operations including Coronary Artery Bypass Graft, valve repair/replacement, or combination of CABG and heart valve operations

Must not have

Patients with evidence of hepatic or renal dysfunctions

Patients with inflammatory conditions such as lupus, severe arthritis, thyroiditis or inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether or not minocycline, a safe and common acne drug, is better at preventing atrial fibrillation than amiodarone, the current standard of care. If minocycline is found to be more effective, it could be incorporated into clinical care for this disease, improving outcomes and reducing costs.

Who is the study for?

This trial is for adults over 18 who've had non-congenital cardiac surgery and can use an iPhone to download ECGs. It's not for those with recent cancer, thyroid issues, current or past atrial fibrillation, severe lung disease, liver/kidney dysfunction, inflammatory diseases, on certain medications like immunosuppressants or steroids, pregnant women, or with a history of substance abuse.

What is being tested?

The study tests if adding Minocycline to Amiodarone reduces the risk of developing atrial fibrillation after heart surgery more effectively than using Amiodarone alone. The goal is to improve patient outcomes and reduce healthcare costs associated with this common post-surgery complication.

What are the potential side effects?

Amiodarone may cause various side effects including issues with the lungs, liver and thyroid; vision changes; skin discoloration; and digestive problems. Minocycline can lead to dizziness, light sensitivity, dental discoloration in children under eight years old (not applicable here), and gastrointestinal upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had heart surgery, including bypass or valve repair/replacement.

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I have had heart surgery, such as bypass or valve repair.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver or kidney problems.

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I have a condition like lupus, severe arthritis, thyroiditis, or inflammatory bowel disease.

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I am on long-term steroids, immunosuppressants, or estrogen replacement.

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I have an overactive thyroid.

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I am having or have had surgery for atrial fibrillation.

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I have severe COPD with low lung function.

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My cancer was diagnosed within the last 5 years.

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I am having a minimally invasive heart valve procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-op Atrial Fibrillation

Secondary study objectives

30-day hospital death

Heart failure

Thromboembolism

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: minocyclineExperimental Treatment2 Interventions

intravenous minocycline 100 mg daily x 5 days starting intra-operatively combined with oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days

Group II: AmiodaroneExperimental Treatment1 Intervention

oral amiodarone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amiodarone

2010

Completed Phase 4

~5380

Minocycline

2019