Minocycline + Amiodarone for Atrial Fibrillation

(MINA Trial)

Not yet recruiting at 1 trial location

Overseen By Abdallah Alameddine, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baystate Medical Center

Must not be taking: Immunosuppressants, Corticosteroids, Estrogen

Disqualifiers: Atrial fibrillation, Hepatic dysfunction, Renal dysfunction, Thyrotoxicosis, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to prevent atrial fibrillation, a heart rhythm problem that can occur after heart surgery. It tests whether adding minocycline, a common acne medication, to the usual heart drug, amiodarone, can reduce these heart issues. The goal is to improve recovery after surgery and lower healthcare costs. Individuals who have undergone major heart surgery, such as bypass or valve operations, and can use an iPhone to share heart data may be suitable candidates. 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 medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressants, long-term oral corticosteroids, or estrogen replacement, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that minocycline is generally safe for people. Studies have used doses up to 10 mg/kg through an IV, and patients tolerated it well, even when combined with other treatments for conditions like stroke. This suggests it might be safe for other uses too.

Amiodarone is a common treatment for atrial fibrillation, an irregular heartbeat. However, it can have side effects and sometimes doesn't completely prevent the condition. This trial tests whether adding minocycline to amiodarone can improve results. While minocycline is often used to treat acne, its potential heart benefits are still under study.

As a Phase 2 trial, this indicates that earlier studies have shown some safety, but researchers are still gathering more information on tolerance. This phase helps ensure that any side effects are identified and managed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining minocycline with amiodarone for atrial fibrillation because this approach may enhance the effectiveness of existing treatments. Unlike standard antiarrhythmic drugs, which mainly focus on restoring heart rhythm, minocycline has anti-inflammatory properties that could address underlying inflammation associated with atrial fibrillation. Additionally, administering minocycline intravenously during surgery might offer a quicker and more targeted intervention, potentially reducing the risk of post-operative atrial fibrillation more swiftly than current options. This combination therapy could offer a dual approach, tackling both the rhythm disturbance and its underlying causes.

What evidence suggests that Minocycline + Amiodarone might be an effective treatment for atrial fibrillation?

This trial will compare the effects of Amiodarone alone with a combination of Minocycline and Amiodarone for preventing atrial fibrillation after heart surgery. Research has shown that combining Minocycline with Amiodarone may help prevent atrial fibrillation, a common heart rhythm problem, after heart surgery. Minocycline reduces inflammation, which might help lower the inflammation linked to atrial fibrillation. Studies on other conditions have demonstrated that Minocycline can protect the body due to these anti-inflammatory effects. Amiodarone is already used to manage heart rhythm, but it can have side effects and might not always work perfectly on its own. By combining these two drugs, the goal is to use their strengths together to better reduce the risk of atrial fibrillation than using Amiodarone alone. ^{1 3 4 6 7}

Who Is on the Research Team?

Abdallah k Alameddine, MD

Principal Investigator

Baystate Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You must have an iPhone and be able to download ECGs onto it.

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

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

Exclusion Criteria

I have liver or kidney problems.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous minocycline combined with oral amiodarone or oral amiodarone alone for prevention of POAF

2 weeks

Daily visits for 5 days, then follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including telemetry, Holter monitoring, or daily wireless ECG sensors

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amiodarone
• Minocycline

Trial Overview 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.

How Is the Trial Designed?

Group I: minocycline Experimental Treatment 2 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: Amiodarone Experimental Treatment 1 Intervention

oral amiodarone

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01422148

NCT01422148 | Minocycline Plus Amiodarone Versus ... In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care ...

2. scirp.org scirp.org/journal/paperinformation?paperid=23703

The rationale and design of the minocycline plus ... This trial compares the efficacy and safety of minocycline plus amiodarone versus amiodarone alone, in the prevention of PAF among adult patients undergoing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3916214/

Minocycline to Improve Neurologic Outcome in Stroke (MINOS) Minocycline is a promising anti-inflammatory and protease inhibitor that is effective in multiple pre-clinical stroke models. We conducted an early phase trial ...

4. withpower.com withpower.com/trial/minocycline-amiodarone-for-atrial-fibrillation-bfcf6

Minocycline + Amiodarone for Atrial Fibrillation (MINA Trial) Trial Overview The study tests if adding Minocycline to Amiodarone reduces the risk of developing atrial fibrillation after heart surgery more effectively than ...

5. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.110.582601

Minocycline to Improve Neurologic Outcome in Stroke ... A recent trial of minocycline in patients with amyotrophic lateral sclerosis revealed a worse outcome in the group treated for 9 months, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3651660/

Minocycline: far beyond an antibiotic - PMC - PubMed Central Various in vivo studies have also described the cardioprotective effects of minocycline, as antibiotic pre- and post-treatment of rats subjected to I/R resulted ...

7. ahajournals.org ahajournals.org/doi/pdf/10.1161/strokeaha.110.582601

Minocycline to Improve Neurologic Outcome in Stroke ( ... Conclusions—Minocycline is safe and well tolerated up to doses of 10 mg/kg intravenously alone and in combination with tissue plasminogen activator. The half- ...