The objective of this study was to assess the effect of Dronedarone on prevention of atrial fibrillation after on-pump coronary bypass graft surgery.
Design of study: a randomized,Not blinded study.
The study population: patients undergoing coronary artery bypass surgery.
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
Intervention: In first group, using Drondarone (BD mg 400) two days before and five days after CABG surgery in addition to standard therapy and in second group will receive only standard treatment (carvedilol 6.25 mg BD). Patients in both groups are investigated by incidence of AF, its duration ,CRP levels and drug side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202011965N2
Registration date:2012-07-16, 1391/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-16, 1391/04/26
Registrant information
Name
Majid Haghjoo
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2163
Email address
majid.haghjoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEffect of Dronedarone on prevention of atrial fibrilation after on-pump coronary bypass graft surgery
Public title
ٍEffect of Dronedarone on prevention of atrial fibrilation
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Tehran university of medical science
Street address
ce chancellor for research, Tehran university of medical science
City
Tehran
Postal code
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
15890
Health conditions studied
1
Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
The incidence of AF
Timepoint
7 days after intervention
Method of measurement
ECG
2
Description
AF duration
Timepoint
7 days after intervention
Method of measurement
ECG/ In minute
Secondary outcomes
1
Description
CRP level
Timepoint
Daily for7 days
Method of measurement
Blood sampling, mg/l
2
Description
ICU stay duration
Timepoint
since being admitted to the ICU
Method of measurement
clinical records of patient
3
Description
Hospital stay duration
Timepoint
since being admitted to the hospital
Method of measurement
clinical records of patient
4
Description
mortality
Timepoint
since being admitted to the hospital
Method of measurement
clinical records of patient
5
Description
drug side effects
Timepoint
until adverse drug reaction
Method of measurement
Examination and clinical records of patient
Intervention groups
1
Description
In the control group, only the standard treatment (Beta-blockers) carvedilol 6.25mg BD will be used preoperatively and 5 days after CABG .
Category
Treatment - Drugs
2
Description
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).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Majid Haghjoo
Street address
Niayesh highway, Vali-Asr Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Fotoohi
Street address
Tehran University of Medical Sciences, Ghods St, Keshavarz Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Cobeldarou
Full name of responsible person
Mr. Memarian
Street address
number 39, Alvand street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cobeldarou
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Majid Haghjoo
Position
Research vice chancellor/ Cardiologist
Other areas of specialty/work
Street address
Niayesh highway, Vali-Asr Ave.
City
Tehran
Postal code
1996911151
Phone
+98 21 2392 2163
Fax
Email
majid.haghjoo@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Majid Haghjoo
Position
Research vice chancellor in Rajaie Cardiovascular Medical and Research Center/ Cardiologist
Other areas of specialty/work
Street address
Niayesh highway, Vali-Asr Ave.
City
Tehran
Postal code
1996911151
Phone
+98 21 2392 2163
Fax
Email
majid.haghjoo@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)