Study of the effect of early bolus dose of tirofiban in emergency department on early TIMI flow 3 of the patients with myocardial infarction undergoing primary PCI
The aim of this study is to consider the effect of early bolus adminstration of tirofiban in emergency department on early TIMI flow of the patients with myocardial infarction undergoing primary PCI. Inclusion criteria are the patients admitted in Tehran heart center emergency department with acute ST elevation myocardial infarction or new left bundle branch block within 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department. Exclusion criteria are contraindications for fibrinolysis, severe hepatic or renal failure, age more than 75 years old and fibrinolytic therapy within 24 hours from randomization. The sample size is 70 for each group. The patients are randomized into the following 2 groups. Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department. The control group will not receive tirofiban. Other drugs are prescribed according to decision of clinician in both groups. The primary endpoint is TIMI flow 3 in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105126463N1
Registration date:2011-06-06, 1390/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2011-06-06, 1390/03/16
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
Tehran Heart Center
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of early bolus dose of tirofiban in emergency department on early TIMI flow 3 of the patients with myocardial infarction undergoing primary PCI
Public title
Effect of early tirofiban adminstration in emergency department on TIMI flow 3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Acute myocardial infarction patient with ST segment elevation or new left bundle branch block in 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department
Exclusion criteria: Stroke or TIA within the past 30 days or any history of hemorrhagic stroke, well known intra cranial disease (neoplasm or aneurysm), any active bleeding or bleeding history in past 30 days, uncontrolled HTN at registry time (SBP>180, DBP>110), Major operation or trauma in recent 6 weeks, platlete count less than 100000 or bleeding conditions, Coagulation disorders (INR>1.5), Severe hepatic failure, Administration of any fibrinolytic treatment 24 hours from randomization, Renal failure (Cr>205mg/dl or GFR <30), age more than 75 years old
Age
To 75 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center Ethic committee
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Postal code
1411713138
Approval date
2011-01-03, 1389/10/13
Ethics committee reference number
460
Health conditions studied
1
Description of health condition studied
acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
TIMI 3 flow score prevalency in coronary angiography
Timepoint
in cath lab before PCI
Method of measurement
according to angiography report
Secondary outcomes
1
Description
Major Cardiac Event
Timepoint
one year
Method of measurement
clinical follow up
Intervention groups
1
Description
Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department.
Category
Treatment - Drugs
2
Description
The control group will not receive tirofiban in emergency department.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr Mehdi Moosavi
Street address
Jalal Al Ahmad & North Kargar Cross
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr Seyed Hesammeddin Abbasi
Street address
North kargar and Jalal al Ahmad cross
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart Center
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
Tehran Heart Center
Full name of responsible person
Dr Seyed Hesameddin Abbasi
Position
Managing editor of Journal of Tehran Heart Center
Other areas of specialty/work
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9702
Fax
+98 21 8802 9256
Email
Abbasi.hesam@gmail.com
Web page address
http://thc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr Mehdi Mousavi
Position
Cardiologist, Fellow of interventional cardiology
Other areas of specialty/work
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9256
Email
mmoosavi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr Neda Ghaffari-marandi
Position
Research associate
Other areas of specialty/work
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9256
Email
nghaffari303@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)