Assessment of Clopidogrel plus Eptifibatide versus Ticagrelor Treatment for No-reflow in patients with acute ST-Elevation MI referring for Primary Percutaneous coronary Intervention
To compare the effects of clopidogrel plus eptifibatide with ticagrelor in patients who are a candidate for emergent angioplasty and acute ST-elevation myocardial infarction in the occurrence of No reflow phenomenon
Design
This will be a single blind, single center, randomized study with two parallel study groups that each of them contains 108 patients. Randomization in each group will be done by the use of a table of random numbers.
Settings and conduct
This trial will be performed at Imam Khomeini hospital. Patients with acute ST-elevation MI, randomly will be divided into two groups, who will receive clopidogrel and eptifibatide or ticagrelor. Patients will be informed about the study and also the risks and benefits of each drug. But they will be blind about the drug that will be used for them. Patients will receive other routine standard care. After coronary angiography, patients with culprit's vessel that its TIMI flow is zero will be included in the study. Patients with cardiogenic shock, candidate for emergent surgery, recent use of clopidogrel, severe valvular heart disease, and presenting more than 12 hours.
Participants/Inclusion and exclusion criteria
Patients with acute ST elevation myocardial infarction who are a candidate for emergent revascularization.
Exclusion criteria are cardiogenic shock, patients who are referred more than 12 hours after symptom onset, recent use of clopidogrel, severe valvular heart disease, emergent cardiac surgery.
Intervention groups
The intervention group will receive clopidogrel plus eptifibatide before and during angioplasty.
The control group will receive ticagrelor before angioplasty.
All of two groups will receive other standard treatments.
Main outcome variables
No-reflow phenomenon
percentage of ST resolution after primary angioplasty
prevalence of minor and major bleeding
prevalence of in-hospital mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200318046810N1
Registration date:2022-01-11, 1400/10/21
Registration timing:retrospective
Last update:2022-01-11, 1400/10/21
Update count:0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
Mohammad Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9537
Email address
m_sadeghian2001@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Clopidogrel plus Eptifibatide versus Ticagrelor Treatment for No-reflow in patients with acute ST-Elevation MI referring for Primary Percutaneous coronary Intervention
Public title
Assessment of Clopidogrel plus Eptifibatide versus Ticagrelor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute chest pain and ST elevation in electrocardiogram
Exclusion criteria:
Patients with recent history of using clopidogrel
Patients presenting with cardiogenic shock
Patients with advanced valvular heart disease
Patients who are candidate for urgent cardiac surgery
Patients presenting more 12 hours after onset of symptoms
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The simple method of randomization by a random number generator will be used. The unit of randomization will be individual and only the patient will be blind about the drug which is used.
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 committe of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Department of cardiology,Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.230
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
No reflow phenomenon
Timepoint
After implantation of stent
Method of measurement
Coronary Angiography views
2
Description
ST resolution in EKG
Timepoint
90 minutes after angiography
Method of measurement
more than 50%decreasing of ST segment
Secondary outcomes
1
Description
major and minor bleeding
Timepoint
after pci
Method of measurement
decreasing of Hb and intracranial bleedind and deadly bleeding
2
Description
MACCE(mortality and CVA and reMI)
Timepoint
after angiography
Method of measurement
the numbering of reMI and CVA and mortality
Intervention groups
1
Description
Clopidogrel plus Ebtifibatide; patients with STEMI that candidate for primary PCI were divided in tow groups of clopidogrel+eptifibatide and ticagrelor. No reflow phenomen after pci was evaluated in two groups
Category
Treatment - Drugs
2
Description
Intervention group: ticagrelor; Patients with STEMI that candidate for primary PCI were divided in tow groups of clopidogrel+eptifibatide and ticagrelor. No reflow phenomen after pci was evaluated in two groups
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Sadeghian
Street address
Department of cardiology,Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9537
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
DR saied sadeghian
Street address
6th Floor, Ghods building, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadeghian
Position
Assistant professor of Tehran University of Medical Science
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9537
Email
msadeghian@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadeghian
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Department of cardiology, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9537
Email
msadeghian@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadeghian
Position
Assistant professor of Tehran University of Medical Science
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9537
Email
msadeghian@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available