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Comparison of cardiovascular outcomes (repeated infarction, infarct size, hemorrhage, and death) of intracoronary abciximab or intravenous eptifibatide administration during percutaneous coronary intervention of ST-segment elevation myocardial infarction

Protocol summary

Summary
The objective of this study is to compare the efficacy of intracoronary abciximab and intravenous eptifibatide in percutaneous coronary intervention of myocardial infarction with ST segment elevation. Inclusion criterion is acute myocardial infarction with ST segment elevation according to clinical, laboratory, and ECG findings. Exclusion criteria are presentation after 12 hours of symptoms onset, those with spastic angina (resolution of ST segment elevation and alleviation of symptoms after intravenous nitroglycerine administration), those with non-ST segment elevation myocardial infarction, history of stroke or intracerebral hemorrhage, contraindication for platelet administration, and cardiogenic shock. Forty STEMI patients were randomized to either intracoronary abciximab or intravenous eptifibatide. Abciximab dosage was 0.25 µg/kg. In another group two boluses (each 180 µg/kg) of eptifibatide were administered every 10 minutes. Outcomes assessed are infarct size, myocardial reperfusion, TIMI grade after intervention, repeated infarction, hemorrhage, and death.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012081310573N1
Registration date: 2012-09-09, 1391/06/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-09, 1391/06/19
Registrant information
Name
Habibollah Saadat
Name of organization / entity
Cardiovascular Research Center, Modarres Hospital, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3106
Email address
h_saadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2011-08-27, 1390/06/05
Expected recruitment end date
2012-03-17, 1390/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cardiovascular outcomes (repeated infarction, infarct size, hemorrhage, and death) of intracoronary abciximab or intravenous eptifibatide administration during percutaneous coronary intervention of ST-segment elevation myocardial infarction
Public title
Efficacy of intracoronary abciximab in percutaneous coronary intervention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ST elevation myocardial infarction (MI) Exclusion criteria: patients presenting with ST-elevation myocardial infarction after 12 hours from symptoms onset; patients presenting with vasospastic angina (determined by resolution of ST segment elevation, and relief of symptoms after intravenous administration of nitroglycerin); patients presenting with non-ST elevation MI; contraindications for antiplatelets such as bleeding disorder including gastrointestinal bleeding, hematuria, or any known bleeding tendency either inherited or acquired; thrombocytopenia (Platelet count less than 100.000 per microliter; recent (less than 6 months) stroke; intracranial hemorrhage at any time in patient's life or any known intracranial malformation; cardiogenic shock; left bundle branch block changes on ECG.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
N/A

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences
Street address
Saadat-Abad Ave.
City
Tehran
Postal code
Approval date
2011-08-25, 1390/06/03
Ethics committee reference number
154/MT

Health conditions studied

1

Description of health condition studied
ST-segment elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset

Primary outcomes

1

Description
Infarct size
Timepoint
Day 2
Method of measurement
Area under the curve of the cardiac creatine kinase-MB release

2

Description
Myocardial reperfusion
Timepoint
First day
Method of measurement
resolution of ST segment elevation

3

Description
Reinfarction
Timepoint
Days 1 to 7
Method of measurement
Recurrent symptoms suggestive of ischemia with new ST-segment elevation and/or elevation of serum cardiac markers levels

Secondary outcomes

empty

Intervention groups

1

Description
In control group, two boluses of eptifibatide (each 180 microgram per kilogram body weight) were administered intravenously 10 minutes apart during percutaneous coronary intervention.
Category
Treatment - Drugs

2

Description
In intervention group, abciximab with a dosage of 0.25 microgram per kilogram body weight was administered into coronary arteries via microcatheter during percutaneous coronary intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiology Department, Modarres Hospital, Tehran, Iran
Full name of responsible person
Habibollah Saadat
Street address
Saadat-Abad Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cardiovascular Research Center, Shahid Beheshti University of Medical sciences
Full name of responsible person
Morteza Safi
Street address
Modarres Hospital, Saadat-Abad Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cardiovascular Research Center, Shahid Beheshti 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
Shahid Beheshti Cardiovascular Research Center
Full name of responsible person
Mohammad Hassan Namazi
Position
Associated Professor of Cardiology
Other areas of specialty/work
Street address
Cardiology Department, Modarres Hospital, Saadat-Abad Ave.
City
Tehran
Postal code
Phone
+98 21 2208 3106
Fax
Email
namazimh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Cardiovascular Research Center
Full name of responsible person
Habibollah Saadat
Position
Associated professor of Cardiology
Other areas of specialty/work
Street address
Cardiology Department, Modarres Hospital, Saadat-Abad Ave.
City
Tehran
Postal code
Phone
+98 21 2208 3106
Fax
Email
h_saadat@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Cardiovascular Research Center
Full name of responsible person
Habibollah Saadat
Position
Associated Professor of Cardiology
Other areas of specialty/work
Street address
Cardiology Department, Modarres Hospital, Saadat-Abad Ave.
City
Tehran
Postal code
Phone
+98 21 2208 3106
Fax
Email
h_saadat@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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