Comparing the protective effect of Ticaglerol versus Clopidogrel on Myocardial resistance index in patients with ST elevation myocardial infarction.
Design
this trial was performed in order to comparing the effect of clopidogrel versus ticaglrol in patients who arrived with STEMI in first 12 hours of symptoms onset and candidate for PPCI. the patients who refer to cath lab and the involvement of single vessel reported they will be enrolled. and they are randomized to two interventional and control groups. IMR was assess with QFR soft ware immidiately after accomplish of procedure. and echocardiography will be performed in the first 24 hours and 3 months after the procedure.
Settings and conduct
this trial was performed as a randomization, open label, parallel arm in shahid rajaiee heart center
Participants/Inclusion and exclusion criteria
Inclusion criteria: more than 18 years old patients with STEMI
Exclusion criteria: multivessel or left main disease,stent thrombosis, cardiogenic shock,history of CVA or MI, contraindication of adenosine, TIMI FLOW less than 3
Comparing the protective effect of Ticaglerol versus Clopidogrel on Myocardial resistance index in patients with ST elevation myocardial infarction.
Public title
Ticagrelor in ST elevation MI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age > 18 years
presented with STEMI
suitable infarcted related artery for angioplasty
patient satisfaction
Exclusion criteria:
More than single vessel involvement in angiography
unprotected leftmain lesion
stent thrombosis
presentation with cardiogenic shock
history of CVA
history of MI
contraindication of adenosine
High degree AV block
TIMI flow < 3 at the end of the angioplasty
patient dissatisfaction
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method with block size of 4 will be done
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
Shahid rajaiee hospital
Street address
Hashemi rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.RHC.REC.1398.076
Health conditions studied
1
Description of health condition studied
Aacut ST elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
intramyocardial resistance
Timepoint
immediately after procedure
Method of measurement
QFR software
Secondary outcomes
1
Description
left ventricle ejection fraction
Timepoint
during first 24 hours and 3 month after procedure
Method of measurement
echocardiography
2
Description
wall motion score index
Timepoint
during first 24 hours and 3 month after procedure
Method of measurement
echocardiography
Intervention groups
1
Description
Intervention group: prescribed 180 mg ( two tablet) Ticagrelor orally as a loading dose before stent deployment in cath lab
Category
Treatment - Drugs
2
Description
Control group: prescribed 600 mg (8 tablet) clopidogrel orally as a loading dose before stent deployment in cath lab
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie Heart Center
Full name of responsible person
Bahram Mohebi
Street address
Heshemi rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
azadeh_m27@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Rajaiee Heart Center
Full name of responsible person
Bahram Mohebi
Street address
Hashemi rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
azadeh_m27@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
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
Iran University of Medical Sciences
Full name of responsible person
Bahram Mohebi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Hashemi rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
roodbar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bahram Mohebi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hashemi rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
roodbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Mozayanimonfared
Position
interventional cardiology resident
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Hashemi rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
a.mozayani@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
patient demographic data and the primary and secondary endpoint data
When the data will become available and for how long
no limitation
To whom data/document is available
all persons
Under which criteria data/document could be used
no limitation
From where data/document is obtainable
connect with email:a.mozayani@umsha.ac.ir or research center of Shaheed rajaiee hospitsl
What processes are involved for a request to access data/document
after receiving the request for accessibility to data,it was reviewing with research expert and then referred to the master of research