Early Anti-Coagulation therapy in new onset atrial fibrillation after coronary artery bypass graft operation; Warfarin vs Rivaroxaban for stroke prevention and risk of bleeding assessment: A randomized clinical trial
Comparative effectiveness of Warfarin vs Rivaroxaban for stroke and transient ischemic attack prevention in new onset atrial fibrillation (AF) after coronary artery bypass graft (CABG) operation as a randomized clinical trial and also major bleeding risk assessment in these two groups
Design
Two arm parallel group open-label 1:1 block randomized trial (each group : 795 patients), Phase 3
Settings and conduct
Patients who undergone Isolated CABG in Tehran Heart Center with newly diagnosed post operative AF, enrolled the 2 arm parallel group 1:1 randomized trial. Regardless of CHA2DS2_VASC criteria, one group will receive Rivaroxaban 72 hours after the diagnosis and the other will receive Warfarin after bridge therapy. The therapeutic range of warfarin is INR 2-3. Both of medications will be continued for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion:Isolated CABG
Two or more episodes of New Onset AF (each lasting > 20 minutes) or persistent atrial fibrillation lasting > 24 hours
Exclusion:History of allergy to study drugs
History of recent stroke before surgery or post-operation before initiation of study medications
At least moderate Mitral or Aortic valve stenosis not repaired or replaced by surgery
Recent or ongoing pregnancy
Any other indication for anticoagulation therapy (Including DVT, PTE, mechanical valve)
Baseline INR > 1.7
History of atrial fibrillation before operation
Postoperative bleeding before initiation of anticoagulation medications
Glomerular filtration rate(GFR)<30 ml/min
Intervention groups
Warfarin
Rivaroxaban
Main outcome variables
Primary out come: Stroke, Transient Ischemic Attack up to 30 days after discharge
Secondary out come: Major bleeding up to 30 days after discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200304046696N1
Registration date:2020-03-18, 1398/12/28
Registration timing:prospective
Last update:2020-03-18, 1398/12/28
Update count:0
Registration date
2020-03-18, 1398/12/28
Registrant information
Name
Mojgan Ghavami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
ghavami_mojgan69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early Anti-Coagulation therapy in new onset atrial fibrillation after coronary artery bypass graft operation; Warfarin vs Rivaroxaban for stroke prevention and risk of bleeding assessment: A randomized clinical trial
Public title
Early Anti-Coagulation therapy in new onset atrial fibrillation after coronary artery bypass graft operation; Warfarin vs Rivaroxaban for stroke prevention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergone Isolated coronary artery bypass graft in Tehran Heart Center
Two or more episodes of New Onset Atrial Fibrillation (each lasting > 20 minutes) or persistent atrial fibrillation lasting > 24 hours
Exclusion criteria:
History of allergy to study drugs
History of recent stroke (within 1 month) before surgery or post-operation before initiation of study medications
At least moderate Mitral or Aortic valve stenosis not repaired or replaced by surgery
Recent (within 1 year) or ongoing pregnancy (Blood pregnancy test (b-HCG level) will be checked for young women at the beginning of the study)
Any other indication for anticoagulation therapy (Including DVT, PTE, mechanical valve)
Baseline INR > 1.7
History of atrial fibrillation before operation
Postoperative bleeding before initiation of anticoagulation medications
Glomerular filtration rate(GFR) < 30 ml/min
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
1590
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using random allocation software, Block size: variable
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 Sciences
Street address
Tehran Heart Center, North Kargar-Ave , Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Approval date
2020-01-29, 1398/11/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.836
Health conditions studied
1
Description of health condition studied
Post Operative Atrial Fibrillation
ICD-10 code
I48.0
ICD-10 code description
Paroxysmal atrial fibrillation
Primary outcomes
1
Description
Stroke or Transient Ischemic Attack (TIA)
Timepoint
Up to 30 days after discharge
Method of measurement
Clinical assessment, Imaging if needed (If neurological examination is favorable for stroke or TIA, the diagnosis will be confirmed by imaging (Brain CT_scan or MRI))
Secondary outcomes
1
Description
Major Bleeding
Timepoint
Up to 30 days after discharge
Method of measurement
Physical Examination_ Bleeding which requires re-operation or other therapeutic intervention for bleeding assessment (e.g colonoscopy, endoscopy and urologic procedures for hematuria), development of any intracranial bleeding (Diagnosis will be confirmed by Brain CT_scan or Magnetic resonance Imaging), transfusion > 2 units of blood after drug initiation
Intervention groups
1
Description
Intervention group: Drug Warfarin administration
Category
Treatment - Drugs
2
Description
Intervention group: Drug Rivaroxaban administration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Mojgan Ghavami
Street address
Tehran Heart Center, North Kargar-Ave , Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
+98 21 8802 9731
Email
Ghavami_mojgan69@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr. ِِMohammad Ali Sahraeian
Street address
Sixth Floor, Vice Chancellor for Research and Technology Departement, Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417993337
Phone
+98 21 8163 3698
Fax
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
30
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
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Ghavami
Position
Cardiology resident, PhD candidate by research
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar-Ave , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
Email
ghavami_mojgan69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Ghavami
Position
Cardiology resident-PhD candidate by research
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar-Ave , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
Email
ghavami_mojgan69@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Ghavami
Position
Cardiology resident, PhD candidate by research
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar-Ave , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
Email
ghavami_mojgan69@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