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Evaluating the Effect of Amiodarone Pretreatment on the Incidence of Atrial Fibrillation Following CABG Surgery: A Triple Blind Placebo-Controlled Clinical Trial

Evaluating the Effect of Amiodarone Pretreatment on the Incidence of Atrial Fibrillation Following CABG Surgery: A Triple Blind Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251228068478N1
Enrollment
180
Registered
2026-02-11
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease in patients undergoing coronary artery bypass grafting, with risk of postoperative atrial fibrillation.. Presence of aortocoronary bypass graft

Interventions

Intervention 1: Intervention group: Patients receive preventive oral amiodarone at a dose of 5 milligrams per kilogram per day, divided into two daily doses, starting 5 days before coronary artery byp

Sponsors

Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria included patients aged =18 years who were admitted to Dr. Heshmat Hospital, Rasht, with non–ST-segment elevation acute coronary syndrome (NSTE-ACS), underwent coronary angiography, were subsequently considered candidates for coronary artery bypass grafting (CABG), remained hospitalized for at least 5 days prior to surgery, and provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria included patients undergoing emergency CABG, CABG combined with valvular surgery, redo CABG, a history of hypersensitivity or toxicity to amiodarone, a prior history of atrial fibrillation, chronic amiodarone therapy, diabetes mellitus, hypothyroidism or hyperthyroidism, hepatic failure, abnormal laboratory findings such as serum creatinine >2 mg/dL or elevations of SGOT or SGPT greater than twice the upper limit of normal, chronic obstructive pulmonary disease, preoperative atrial fibrillation, pregnancy, moderate or greater left atrial enlargement on echocardiography, bradycardia with a heart rate <50 beats per minute, left ventricular ejection fraction <40%, or refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of atrial fibrillation after coronary artery bypass grafting surgery. Timepoint: Continuous monitoring during the first six days after surgery, including intensive care unit and hospital ward stay. Method of measurement: Electrocardiogram monitoring using hospital standard electrocardiogram devices.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiloufar Akbari Parsa

Guilan University of Medical Sciences

dr.niloufar.parsa@gmail.com+98 13 3334 5308

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026