Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaystate Medical Center

About this trial

. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amiodarone

    Drug

    oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days

  • Minocycline

    Drug

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: AmiodaroneOther 1 intervention
Group B: minocyclineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Thromboembolism

cerebral or pulmonary

Time frame
6 weeks
2

Heart failure

Symptoms include dyspnea, leg edema, low Ejection Fraction, high Central Venous Pressure, high level of natriuretic hormone

Time frame
6 weeks
3

30-day hospital death

cardiac or overall

Time frame
30-days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: