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Comparison of the efficacy of Atorvastatin and Rosuvastatin in atrial fibrillation incidence after coronary artery bypass graft surgery (CABG)

Protocol summary

Study aim
Comparison of the efficacy of Atorvastatin and Rosuvastatin in atrial fibrillation incidence after coronary artery bypass graft surgery(CABG)
Design
Clinical trial with two parallel groups, double blind, randomised, phase 2 on 104 patients, in block randomization method with the size of 4 and 6, Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The aim of the study is comparison of the efficacy of Atorvastatin and Rosuvastatin in reducing of atrial fibrillation incidence after coronary artery bypass graft surgery in 104 patients of Amiralmomenin hospital in Arak city.In first group Atorvastatin 40 mg tablet and in second group Rosuvastatin 20 mg tablet orally will be used after surgery when patient can use oral nutrition, daily for one week.patients will be in group one or two, randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All of patients reffered to Amiralmomenin hospital for elective CABG surgery Patients with 40 or more than 40 EF Patients with On-pump method in surgery Exclusion criteria: Recent MI Using of antiarhythmic drugs especially Amiodarone History of AF Valvular dysfunction Other surgeries with CABG Organic disease (i.e chronic renal failure stage 3 and 4), thyroid dysfunction, immunosuppression, cancer, central nervous system disease, brain vessels disease and history of CerebroVascular Accident, hormonal diseases, rise of liver enzymes) Hypo/hyperkalemia Dialysis (abnormal Cr) Use of anti-inflammatory drugs Psychological disorders
Intervention groups
In first group Atorvastatin 40 mg tablet and in second group Rosuvastatin 20 mg tablet orally will be used after surgery when patient can use oral nutrition, daily for one week.
Main outcome variables
Frequency of post CABG atrial fibrillation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201028049175N2
Registration date: 2021-01-13, 1399/10/24
Registration timing: prospective

Last update: 2021-01-13, 1399/10/24
Update count: 0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Atorvastatin and Rosuvastatin in atrial fibrillation incidence after coronary artery bypass graft surgery (CABG)
Public title
Comparison of the efficacy of Atorvastatin and Rosuvastatin in atrial fibrillation incidence after coronary artery bypass graft surgery (CABG)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All of patients reffered to Amiralmomenin hospital for elective CABG surgery Patients with 40 or more than 40 EF Patients with On-pump method in surgery
Exclusion criteria:
Recent MI Using of antiarhythmic drugs especially Amiodarone History of AF Valvular dysfunction Other surgeries with CABG Organic disease (i.e chronic renal failure stage 3 and 4), thyroid dysfunction, immunosuppression, cancer, central nervous system disease, brain vessels disease and history of CerebroVascular Accident, hormonal diseases, rise of liver enzymes) Hypo/hyperkalemia Dialysis (abnormal Cr) Use of anti-inflammatory drugs Psychological disorders
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of specific codes that are obtained by the website.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients blindness: All patients are unaware about the name of drugs and the shape and size of drugs are similar. Researcher blindness: According to doctor's prescription, drugs will be given to the patients by nurses; so researcher's doctor filled the check lists is blind about the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.ARAKMU.REC.1399.286

Health conditions studied

1

Description of health condition studied
Atrial fibrillation after CABG
ICD-10 code
I48.0
ICD-10 code description
Paroxysmal atrial fibrillation

2

Description of health condition studied
Atrial fibrillation after CABG
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft

Primary outcomes

1

Description
Frequency of post CABG atrial fibrillation
Timepoint
As starting drug till 7 days after surgery
Method of measurement
Heart monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Atorvastatin 40 mg tablet orally will be used after surgery when patient can use oral nutrition, daily till 7 days after surgery.
Category
Treatment - Drugs

2

Description
Intervention group:Rosuvastatin 20 mg tablet orally will be used after surgery when patient can use oral nutrition, daily till 7 days after surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Alireza Rostami
Street address
Amiralmomenin hospital street, Basij square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Position
lecturer
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
alikamaliir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Elham Farahani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shahid Shiroudi street, Parastar square, Amirkabir hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
08633134715-19
Email
farahani13025@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
shamim valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
sh.valibak@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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