comparing the effect of aspirin and the combination of aspirin with Osvix after surgery, on surgery outcomes in patients are candidates for Coronary artery bypass grafting
comparing the effect of aspirin and the combination of aspirin with Osvix after surgery, on surgery outcomes in patients are candidates for Coronary artery bypass grafting
Design
The study of the two-course clinical trial of 130 patients was randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
candidates for Coronary artery bypass grafting in Amiralmomenin hospital in Arak are divided into 2 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:both of gender, candidates for Coronary artery bypass grafting
Exclusion criteria: dissatisfaction, death
Intervention groups
First group: receive aspirin 80mg (Jalinos company) daily.
Second group: is given aspirin 80mg (Jalinos company) daily and Osvix(Osveh company) daily at a dose of 75 mg, both for three months at 12 noon.
Main outcome variables
Incidence of myocardial infarction, bleeding, platelet count, cell pack count, FFP received
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N157
Registration date:2021-04-25, 1400/02/05
Registration timing:prospective
Last update:2021-04-25, 1400/02/05
Update count:0
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effect of aspirin and the combination of aspirin with Osvix after surgery, on surgery outcomes in patients are candidates for Coronary artery bypass grafting
Public title
comparing the effect of aspirin and the combination of aspirin with Osvix after surgery, on surgery outcomes in patients are candidates for Coronary artery bypass grafting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both of gender
Candidates for Coronary artery bypass grafting
Exclusion criteria:
dissatisfaction
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B . In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.ARAKMU.REC.1399.277
Health conditions studied
1
Description of health condition studied
Coronary artery bypass grafting
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts
Intervention group: is given aspirin 80 mg (Jalinos company) daily and Osvix (Osveh company) daily at a dose of 75 mg, both for three months at 12 noon.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
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
Dr Alireza rostami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Amiralmomenin hospital, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Rostami@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street