Protocol summary
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Study aim
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ْ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.
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Design
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Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
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Settings and conduct
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Tehran heart center
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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ُEarly TIMI flow of the patients with myocardial infarction undergoing primary PCI.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201105126463N1
Registration date:
2011-06-06, 1390/03/16
Registration timing:
registered_while_recruiting
Last update:
2018-04-04, 1397/01/15
Update count:
1
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Registration date
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2011-06-06, 1390/03/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran Heart Center
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Expected recruitment start date
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2011-03-06, 1389/12/15
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Expected recruitment end date
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2012-03-05, 1390/12/15
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Actual recruitment start date
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2011-03-06, 1389/12/15
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Actual recruitment end date
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2012-03-19, 1390/12/29
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of early tirofiban adminstration in emergency department on TIMI flow 3
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion 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:
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
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Age
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To 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
140
Actual sample size reached:
140
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Are blinded by coding to the subjects
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2011-01-03, 1389/10/13
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Ethics committee reference number
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460
Health conditions studied
1
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Description of health condition studied
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acute myocardial infarction
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ICD-10 code
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I21
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ICD-10 code description
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Acute myocardial infarction
Primary outcomes
1
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Description
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Prevalence of TIMI 3 flow score in coronary angiography
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Timepoint
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in cath lab before PCI
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Method of measurement
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according to angiography report
Secondary outcomes
1
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Description
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Major Cardiac Event
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Timepoint
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one year
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Method of measurement
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clinical follow up
Intervention groups
1
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Description
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Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department.
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Category
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Treatment - Drugs
2
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Description
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The control group will not receive tirofiban in emergency department.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The article
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When the data will become available and for how long
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Mar 2018
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To whom data/document is available
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Anyone
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Under which criteria data/document could be used
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No other documents
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From where data/document is obtainable
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The corresponding author
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What processes are involved for a request to access data/document
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Email to corespounding author
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Comments
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