Objective: to suggest a new protocol for anti coagulation in patients undergoing coronary artery bypass graft/ coronary endarterectomy.
Design:randomised double blind clinical trial.
Setting and conduct:in group 1,patients are given warfarin(international normalized ratio between 2 - 3)and aspirin(80 mg daily) for 3 months.in group 2 patients are given plavix(75 mg daily) and aspirin(80 mg daily)for 3 months.
inclusion criteria: patients undergoing CABG / coronary endarterectomy
Exclusion criteria were as follows : need to concomitant valve surgery ; history of allergic reaction to Aspirin and Plavix; any systemic disease.
Main outcome measures:electrocardiography, cardiac enzyme levels,; wall motion score inex, ejection fraction in echocardiography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102730410N2
Registration date:2016-11-14, 1395/08/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Ghasem Faghanzadeh Ganji
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8308
Email address
gh.faghanzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Science
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A novel protocol for anti coagulation therapy after coronary endarterectomy in coronary artery bypass graft patients
Public title
the effect of plavix in post coronary artery bypass graft/coronary endarterectomy patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients undergoing Cronary artery bypass graft / coronary endarterectomy
Exclusion criteria were as follows : need to concomitant valve surgery ; history of allergic reaction to Asprin and Plavix; any systemic disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Babol University of Medical Sciences
Street address
Babol University of Medical Science, Ganj Afrooz Avenue, Babol, Mazandaran, Iran Babol
before operation, immediatelly after operation, 24 hours after operation, 48 hours after operation
Method of measurement
serology
2
Description
electrocardiography
Timepoint
before operation, immediatelly after operation, 24 hours after operation, 48 hours after operation
Method of measurement
Electerocardiograph
Secondary outcomes
1
Description
Ejection fraction
Timepoint
before operation, 3 month after operation
Method of measurement
ecocardiograph
2
Description
wall motion score index
Timepoint
before operation, 3 month after operation
Method of measurement
ecocardiograph
Intervention groups
1
Description
the patients are given two drugs from first day until 3 months post operation: Aspirin 80 mg daily and Plavix 75 mg daily.
Category
Treatment - Drugs
2
Description
the patients are given two drugs from first day until 3 months post operation: Aspirin 80 mg daily and Warfarin keeping international normalized ratio between 2-3