A comparison of complication & major cardiovascular events of bolus eptifibatide versus bolus plus infusion of eptifibatide in Primary PCI in patients with acute ST-elevation myocardial infarction
The bleeding complication and in-hospital major cardiovascular events of bolus eptifibatide versus bolus plus the infusion of eptifibatide in patients undergoing primary PCI.
Design
This is a randomized double-blind clinical trial
The sample size is 163 patients in each group
The intervention group will receive a 2 mcg/kg/min infusion of eptifibatide of a single vial of 75 mg /100 ml (Short term protocol).
The control group will receive the same amount and duration of normal saline.
Settings and conduct
ْThe study will be done in Shahid Rajaee Hospital Karaj, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Ischemic heart attack symptoms that last more than 20 minutes and less than 12 hours with 1mm st elevation in 2 limb leads or 2mm st elevation in 2 precordial leads who are candidates for primary PCI intervention.
Exclusion criteria:
Not acceptance of informed consent
History of sensitivity to eptifibatide, heparin, or aspirin
Recent treatment with warfarin (INR>2), fibrinolytic or other IIbIIIa inhibitors
Platelet <100000/mcL
Known bleeding disorder
History of ischemic cerebrovascular accident in previous 30 days
History of hemorrhagic cerebrovascular accident
Abnormal bleeding within 30 days.
Major surgery in previous 6 weeks
Renal failure with hemodialysis
Uncontrolled hypertension (SBP>200mmHg, or DBP>110mmHg
Intervention groups
The intervention group will receive eptifibatide bolus without the infusion
The Control group will receive eptifibatide bolus with placebo infusion
Main outcome variables
Presence of vascular or bleeding complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110512006463N3
Registration date:2021-03-17, 1399/12/27
Registration timing:registered_while_recruiting
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Mehdi Mousavi
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0030
Email address
mmoosavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-01, 1397/01/12
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of complication & major cardiovascular events of bolus eptifibatide versus bolus plus infusion of eptifibatide in Primary PCI in patients with acute ST-elevation myocardial infarction
Public title
Bolus eptifibatide versus bolus plus infusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptoms of ischemic heart attack that last no longer than 12 hours with 1 mm ST elevation in at least 2 limb leads or 2 mm ST elevation in at least 2 precordial leads who are candidates for Primary PCI intervention.
Exclusion criteria:
Not acceptance of informed consent
History of sensitivity to eptifibatide, heparin or aspirin
Recent treatment with warfarin (INR>2), fibrinolythics or other IIbIIIa inhibitors
Platelet <100000/mcL
Known bleeding disorder
History of ischemic cerebrovascular accident in previous 30 days
History of hemorrhagic cerebrovascular accident
Abnormal bleeding in recent 30 days.
Major surgery in previous 6 weeks
Renal failure with dependency to hemodialysis
Uncontrolled hypertension (SBP>200mmHg, or DBP>110mmHg)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
163
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was done using the website of:
"https://www.sealedenvelope.com/simple-randomiser/v1/lists"
The treatment group was put in pockets to be used during the study and the study group was determined according to the content of pockets
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, the control group received normal saline as the placebo with the same volume and time duration as the intervention group.
Patients are blinded to the received medication.
The outcome assessor will be blinded to the treatment allocation group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz Medical School
Street address
Alborz university of medical sciences- North Taleghani Blvd, Karaj, Iran
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.ABZUMS.REC.1399.221
Health conditions studied
1
Description of health condition studied
Acute ST elevation myocardial infarction
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site
2
Description of health condition studied
Acute ST elevation myocardial infarction
ICD-10 code
I21.0
ICD-10 code description
ST elevation (STEMI) myocardial infarction of anterior wall
3
Description of health condition studied
Acute ST elevation myocardial infarction
ICD-10 code
I21.1
ICD-10 code description
ST elevation (STEMI) myocardial infarction of inferior wall
4
Description of health condition studied
Acute ST elevation myocardial infarction
ICD-10 code
I21.2
ICD-10 code description
ST elevation (STEMI) myocardial infarction of other sites
Primary outcomes
1
Description
Vascular or bleeding complication
Timepoint
During in-hospital admision
Method of measurement
Questionnaire and physical exam
Secondary outcomes
1
Description
Death
Timepoint
2 days and 6 months after intervention
Method of measurement
Questionnaire, Electronic file
2
Description
Myocardial infarction
Timepoint
2 days and 6 months after intervention
Method of measurement
ECG and increase in CKMB
3
Description
Need for target lesion revascularization (TLR)
Timepoint
2 days and 6 months after intervention
Method of measurement
Questionnaire, Electronic file
4
Description
Need for target vessel revascularization (TVR)
Timepoint
2 days and 6 months after intervention
Method of measurement
Questionnaire, Electronic file
5
Description
Need for coronary artery bypass graft (CABG)
Timepoint
2 days and 6 months after intervention
Method of measurement
Questionnaire, Electronic file
6
Description
Cerebrovascular accidents
Timepoint
2 days and 6 months after intervention
Method of measurement
Questionnaire, Electronic file
Intervention groups
1
Description
Intervention group will receive 2 bolus doses of eptifibatide (Merk) with dose of 180mcg/kg with 10 minute interval. Then they will receive 2mcg/kg/min of eptifibatide infusion; totally 1 vial of 75mg/cc (short term protocol)
Category
Treatment - Drugs
2
Description
Control group: will receive 2 bolus doses of eptifibatide (Merk) with a dose of 180mcg/kg with a 10-minute intervals. Then they will receive normal saline as the placebo with the same volume and time duration as the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajae hospital, Karaj, Iran
Full name of responsible person
Dr. Mehdi Musavi
Street address
R and D unit, Shahid Rajaei hospital, Shahid Rajei Ave, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
moosavi_m_md@yahoo.com
Web page address
https://rajaei.abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology of Alborz University of Medical Sciences
Full name of responsible person
Dr.Mohamad Noorisepehr
Street address
Deputy of research and technology of Alborz university of medical sciences, Safarian Av, Golshahr, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Fax
+98 26 3455 4484
Email
research@abzums.ac.ir
Web page address
https://research.abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Alborz 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
ِAlborz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Sehati
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
R and D unit, Shahid Rajaei Hospital, Shahid Rajaei Ave, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
F_sehati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Sehati
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
R and D unit, Shahid Rajaei Hospital, Shahid Rajai Ave, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
f_sehati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mehdi Mousavi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
R and D unit, Shahid Rajai Hospital, Shahid Rajai Ave, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 264570030
Fax
+98 26 3455 4484
Email
moosavi_m_md@yahoo.com
Web page address
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data after deidentification
When the data will become available and for how long
After publishing the article
To whom data/document is available
Investigatores
Under which criteria data/document could be used
Email to correspounding author
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document