A comparison of the effectiveness, side effects and acceptability of Plavix and Osivix as anti platelet tablets in patients undergoing Coronary artery by pass.
Anticoagulant effect of clopidogrel is utmost importance in coronary artery disease, especially in prevention of coronary stent thrombosis. Recently, a new local brand of clopidogrel has been launched, as Osvix® (by OSVEH Company, Tehran, Iran). This researchi s conducted by the aim in order to compare two locally prepared clopidogrel brands (Osvix® & Plavix®), in terms of the effect on inhibition of platelet aggregation in patients with coronary artery disease.
This is a double blind randomized study. Sample population consisting of 80 patients, is admitted at Ekbatan Hospital (Hamadan, Iran) for the management of coronary artery disease. Platelet aggregation tests of all these patients will measure (by Iran Blood transfusion organization) by factors of PRP, ADP and placket count. Patients received Plavix® and Osvix® treatments regimens for one month periodically after by-pass coronary surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112178428N1
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Behzad Imani
Name of organization / entity
Science Hamadan University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1017
Email address
b.imani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-02-05, 1390/11/16
Expected recruitment end date
2013-08-04, 1392/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effectiveness, side effects and acceptability of Plavix and Osivix as anti platelet tablets in patients undergoing Coronary artery by pass.
Public title
A comparison of the efficacy of Plavix and Osivix in patients undergoing Coronary artery by pass
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing open heart surgery
Exclusion criteria: 1- Patients with a prior events of acute coronary syndrome, 2- Hepatic insufficiency, 3- History of significant bleeding disorder,4- Those already taking anti-platelet and/or anticoagulant therapy, 5- Age less than 20 and over than 75.
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Hamadan University of Medical Sciences
Street address
Reseach Deputy, Hamadan University of Medical Scinces, Hamadan, Iran.
City
Hamadan
Postal code
6518133265
Approval date
2012-12-17, 1391/09/27
Ethics committee reference number
3214 /9 /35 /16
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Platelet-rich plasma
Timepoint
30 days after heart surgery
Method of measurement
Aggregometry
Secondary outcomes
1
Description
Adenosine diphosphate
Timepoint
30 days after heart surgery
Method of measurement
Aggrigometry
Intervention groups
1
Description
at this clinical trial study, the control group consists of 40 patients recieve Plavix tablets as an antiplatetlet agent. The prescribed dose is 75 mg of Clopidogrel per day for each group. It should be noted that all patients receive 100 mg aspirin tablet daily. In order to implementation of Ex-vivo analysis, blood is mixed with 3.8% citrate and platelet aggregometry is conducted. The amount of Adenosine diphosphate, platelet-rich plasma and platelet count is measured as indicating factors of aggrigation.
Category
Treatment - Drugs
2
Description
at this clinical trial study, the intervantion group consists of 40 patients recieve Osvix tablets as an antiplatetlet agent. The prescribed dose is 75 mg of Clopidogrel per day for each group. It should be noted that all patients receive 100 mg aspirin tablet daily. In order to implementation of Ex-vivo analysis, blood is mixed with 3.8% citrate and platelet aggregometry is conducted. The amount of Adenosine diphosphate, platelet-rich plasma and platelet count is measured as indicating factors of aggrigation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital, Hamadan,Iran.
Full name of responsible person
Behzad Imani
Street address
Operating-room Departemnt, Hamadan University of Medical Sciences, Mahdieh St., Hamadan, Iran.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Hamadan University of Medical Sciences
Full name of responsible person
Behzad Imani
Street address
Operating-room Departemnt, Hamadan University of Medical Sciences, Mahdieh St., Hamadan, Iran.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Hamadan University of Medical Sciences
Proportion provided by this source
100
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
Hamadan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Faculty member, Master of Sciences in Nursing
Other areas of specialty/work
Street address
Operating-room departemnt, Hamadan University of Medical Sciences, Mahdieh St., Hamadan, Iran.
City
Hamadan
Postal code
Phone
+98 81 1838 1017
Fax
+98 81 1838 1043
Email
b.imani@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Reza Safiaryan
Position
Faculty member, Cardiac Surgery Specialist
Other areas of specialty/work
Street address
Surgery Departemnt, Hamadan University of Medical Sciences, Mahdieh St., Hamadan, Iran.
City
Hamadan
Postal code
Phone
+98 81 1252 0684
Fax
Email
safiaryan@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Faculty member, Master of Sciences in Nursing
Other areas of specialty/work
Street address
Operating room departemnt, Hamadan University of Medical Sciences, Mahdieh St., Hamadan, Iran.
City
Hamadan
Postal code
Phone
+98 81 1838 1017
Fax
Email
b.imani@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)