A Phase 2 interventional study of Amiodarone and Minocycline in Atrial Fibrillation, sponsored by Baystate Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Baystate Medical Center · Phase 2, Interventional, and Prevention
NOT ENOUGH PARTICIPANTS
Among 993 studies in Atrial Fibrillation with a site in United States — 161 open to participants now, 220 under way, 15 of them phase 3. Atrial Fibrillation · United States.
Among the 993 studies in Atrial Fibrillation with a site in United States, this one is the 647th largest by enrollment of the 679 interventional ones, is one of 41 that started in 2025, is one of 55 in phase 2, and was the 226th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
Browse Atrial Fibrillation studies →161 of the 993 studies in Atrial Fibrillation with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →993 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 41 started in 2025.
Median enrollment 127 across the 679 interventional studies, 200 across the 308 observational. Of the 675 that completed or were terminated, 304 (45%) have results posted.
349 of 993 have an industry lead sponsor. The 10 most frequent:
Baystate Medical Center is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
Baystate Medical Center has 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
74 of the studies in Atrial Fibrillation with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06376916Phase 3Wake Forest University Health SciencesComparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR | 2026-12 |
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT03907046Phase 3Yale UniversityAnticoagulation in ICH Survivors for Stroke Prevention and Recovery | 2027-04 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02750319Phase 3Memorial Sloan Kettering Cancer CenterAmiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery | 2027-04 |
Among the 993 studies in Atrial Fibrillation with a site in United States, from their registry updates:
. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs.
In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. 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 of this disease.
New-onset postoperative atrial fibrillation after cardiac surgery (POAF) is commonly observed and it increases morbidity, mortality, and health care expenditure. Amiodarone administration is proposed initial agent for prevention and treatment of POAF, but while useful, this drug has a number of adverse side-effects and relapse requiring anticoagulation therapy at hospital discharge is prevalent. Effective medications are needed with respect to management. Minocycline, an old tetracycline antibiotic, has additional effects including inhibition of atrial myocyte apoptosis.The finding that apoptosis of right atrial myocytes is thought to be one etiologic factor underlying POAF supports examining the hypothesis in this project that adding minocycline to amiodarone could favorably reduce POAF frequency rate. Minocycline has been used for over four decades and has a good safety profile, therefore this investigation is not a phase I trial. With a limited sample size, while the data of our MINAA Exploratory trial (the Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery) were not sufficient to draw definite conclusions, rather they suggested feasibility of such therapy in this cohort. In the current pilot study, we assess the clinical effectiveness and safety of minocycline plus amiodarone in preventing POAF with a larger cohort of two parallel groups (n=40, each) randomly assigned in a 1:1 ratio.In this trial we compare 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), versus the same dose oral amiodarone alone, for prevention of POAF among adult patients undergoing coronary artery bypass grafts, heart valve repair or replacement, or combined procedures. All patients receive 150 mg intravenous amiodarone intraoperatively and a 2nd similar dose of amiodarone bolus is permitted for tachyarrhythmia any time within 24 hours after surgery.The primary outcome is a newly detected POAF by telemetry, Holter monitoring, or by daily wireless ECG sensors within 6 weeks from the time of randomization. Composite secondary outcomes include death at 30 days, length of hospital stay, and other adverse events.To elucidate how minocycline causally elicits its pharmacologic effects, sera sampling of biomarkers such as NF-Kappa B, cleaved caspase-3, and NT-pro-BNP are measured pre-procedure, then on the 3rd and 5th postoperative days. If the proposed intervention is successful, it underscores what can ensue when the target evolves to the common population level requiring a nuanced approach pursued by Phase III-IV proposals
Inclusion criteria are adults, including women and minorities > 18 years of age, who are also willing to participate for the duration of the trial (6 weeks). All non-congenital cardiac operations are included: Coronary Artery Bypass Graft, valve repair/replacement, or combination of CABG and heart valve operations. Patients should be able to access iPhones and download ECGs using their electronic Devices. Exclusion criteria Patients with prior (within 6 months) or current atrial fibrillation (AF) or flutter, patients undergoing concomitant surgical AF ablation or a history of AF, transcatheter aortic valve replacement or other minimally invasive procedures, prior cerebrovascular event, cardiogenic shock or resuscitation, evidence of hepatic or renal dysfunctions (i.e., an level that is ≥ twice the , or either a serum creatinine level that is ≥ 2.0 mg/dL or need for preoperative dialysis) are excluded. Other exclusion criteria are the following: thyrotoxicosis, pregnancy, severe (COPD, with /FVC \<70%), recent history of drug or alcohol abuse, and intolerance to tetracycline or amiodarone. Because a core scientific basis of this trial concerning the role of underlying atrial tissue inflammatory/apoptotic activity, patients with inflammatory conditions such as lupus, severe arthritis, thyroiditis or inflammatory bowel disease are excluded; as are patients taking preoperative agents, long-term (>10 days) oral (prednisolone > 10mg or other), or estrogen replacement; and finally patients with newly diagnosed cancer (\<5 years) are also excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral amiodarone
Drug: Amiodarone
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
Drug: Amiodarone · Drug: Minocycline
oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days
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
Also known as: Minocin
Post-op Atrial Fibrillation
frequency of a newly detected episode of POAF occuring after the initial surgery, or within 6 weeks after hospital discharge
Time frame: 6 weeks
Thromboembolism
cerebral or pulmonary
Time frame: 6 weeks
Heart failure
Symptoms include dyspnea, leg edema, low Ejection Fraction, high Central Venous Pressure, high level of natriuretic hormone
Time frame: 6 weeks
30-day hospital death
cardiac or overall
Time frame: 30-days
Plan to share: Yes — yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Three years
Access criteria: de-identified computerized dataset
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Jul 2025 → Sep 2025, on Sep 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
NOT ENOUGH PARTICIPANTS
NOT ENOUGH PARTICIPANTS
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Minocycline
Baystate Medical Center