?Effect of Dronedarone on prevention of atrial fibrilation

?Effect of Dronedarone on prevention of atrial fibrilation after on-pump coronary bypass graft surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201202011965N2

Enrollment

100

Registered

2012-07-16

Start date

2012-04-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Atrial Fibrillation. Atrial fibrillation and flutter

Interventions

Intervention 1: In the control group, only the standard treatment (Beta-blockers) carvedilol 6.25mg BD will be used preoperatively and 5 days after CABG . Intervention 2: In the intervention group, D

Treatment - Drugs

In the control group, only the standard treatment (Beta-blockers) carvedilol 6.25mg BD will be used preoperatively and 5 days after CABG .

In the intervention group, Dronedarone (400 mg BD) will be used preoperatively and 5 days after CABG in addition to standard therapy (using beta-blockers).

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age over 20 years; the first time, On-pump CABG Exclusion criteria: Previous history of AF / AFL; AV block grade 2 and above; Sinus bradycardia with heart rate below 60 bpm; Hemodynamic instability (SBP <100 mmHg); Use of class I or III antiarrhythmia drugs and the other drugs that increase the QT; Uncontrolled heart failure (NYHA class III or IV); Severe liver disease; Valve replacement surgery at the same time; Hypercalemia (K <3.5 mmol / L) or uncontrolled hypermagnesiumia; Severe renal insufficiency (GFR <10 ml / min); Pregnancy and lactation; Amiodarone injection during CABG

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The incidence of AF. Timepoint: 7 days after intervention. Method of measurement: ECG.;AF duration. Timepoint: 7 days after intervention. Method of measurement: ECG/ In minute.	—

Secondary

Measure	Time frame
CRP level. Timepoint: Daily for7 days. Method of measurement: Blood sampling, mg/l.;ICU stay duration. Timepoint: since being admitted to the ICU. Method of measurement: clinical records of patient.;Hospital stay duration. Timepoint: since being admitted to the hospital. Method of measurement: clinical records of patient.;Mortality. Timepoint: since being admitted to the hospital. Method of measurement: clinical records of patient.;Drug side effects. Timepoint: until adverse drug reaction. Method of measurement: Examination and clinical records of patient.	—

Measure

Time frame

CRP level. Timepoint: Daily for7 days. Method of measurement: Blood sampling, mg/l.;ICU stay duration. Timepoint: since being admitted to the ICU. Method of measurement: clinical records of patient.;Hospital stay duration. Timepoint: since being admitted to the hospital. Method of measurement: clinical records of patient.;Mortality. Timepoint: since being admitted to the hospital. Method of measurement: clinical records of patient.;Drug side effects. Timepoint: until adverse drug reaction. Method of measurement: Examination and clinical records of patient.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Majid Haghjoo

Rajaie Cardiovascular Medical and Research Center

majid.haghjoo@gmail.com+98 21 2392 2163

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026