Comparison of ticagrelor with clopidogrel on myocardial blood flow and prognosis of patients with acute myocardial infarction undergoing primary percutaneous coronary intervention
Comparison of Ticagrelor versus Clopidogrel in patients with acute myocardial infarction undergoing primary Percutaneous Coronary Intervention
Design
A clinical trial study with a control group with a parallel and double-blind randomized group on 140 patients. Block randomization method will be used for randomization.
Settings and conduct
A total of 140 patients with STEMI referred to Boali Sina Hospital, Qazvin, will be randomly divided into two treatment groups of 70 patients. The intervention group and control group will receive ticagrelor and clopidogrel, respectively. Patients in both groups will followe up to 3-month period after intervention.
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
Thrombosis, Duration of hospitalization, Death, Bleeding Time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210718051935N1
Registration date:2021-08-16, 1400/05/25
Registration timing:registered_while_recruiting
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Fatemeh Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 1733
Email address
f_rajabi_r@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2022-03-23, 1401/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ticagrelor with clopidogrel on myocardial blood flow and prognosis of patients with acute myocardial infarction undergoing primary percutaneous coronary intervention
Public title
Comparison of Ticagrelor versus Clopidogrel in patients with acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years
Presented with ST-Elevation Myocardial Infarction (STEMI)
Suitable infarcted related artery for angioplasty
Patient satisfaction
Exclusion criteria:
More than single vessel involvement in angiography
Unprotected left main lesion in angiography
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
3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Dept of research Qazvin University of Medical Sciences, Shahid Beheshti Ave
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2021-07-18, 1400/04/27
Ethics committee reference number
IR.QUMS.REC.1400.174
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Thrombosis
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Clinical signs and laboratory tests
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
3 months after the intervention
Method of measurement
Use of patient records
2
Description
Death
Timepoint
3 months after the intervention
Method of measurement
Use of patient records
3
Description
Bleeding Time
Timepoint
3 months after the intervention
Method of measurement
Use of patient records
Intervention groups
1
Description
Intervention group: Ticagllor group: for patients will be prescribed 180 mg of ticaglor loading dose and then 75 mg ticaglor twice a day as maintenance dose for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Clopidogrel group: patients will receive 600 mg of clopidogrel as a loading dose and then clopidogrel 75 mg daily will be prescribed for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Sina Hospital
Full name of responsible person
Fatemah Rajabi
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
F_rajabi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh
Street address
Department of Research Qazvin University of Medical Sciences, Shahid Beheshti Ave
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemah Rajabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
F_rajabi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Rajabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
F_rajabi_r@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Rajabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
F_rajabi_r@yahoo.com
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:F_rajabi_r@yahoo.com or research center of Boali Sina Hospital
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