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Comparison of the efficacy of intracoronary and intravenous Eptifibatide and intracoronary Retaplase on coronary blood flow in patients undergoing PPCI at Dr.Heshmat hospital during 2017-2018 (Randomized clinical trial study)

Protocol summary

Study aim
Determining the Effectiveness of intracoronary and intravenous Eptifibatide and Intracoronary Reteplase on coronary artery blood flow in patients with primary percutaneous coronary intervention
Design
In this study, 160 patients who had the first acute myocardial infarction with ST elevation and who were referred to Dr.Heshmat Hospital in Rasht and who are candidates for primary angioplasty are selected. Participants are randomly assigned to three intervention groups and a control group.
Settings and conduct
This study will be conducted in patients referring to Dr.Heshmat heart hospital in Rasht , who are undergoing primary angioplasty.
Participants/Inclusion and exclusion criteria
patients 18 to 80 years of age who had STEMI for the first time and less than 12 hours of onset of symptoms has spent, and the decision to perform primary PCI is taken for them will enter the study.Patients having normal blood flow in angiography or requiring coronary artery bypass surgery are excluded from the study.
Intervention groups
Group 1: Patients who will embeded a stent after thrombosuction. Group 2: Patients who receive 180 microgram / kg of eptifibatide by intracoronary bolus in 10 minutes interval , and then stent is inserted. Group 3: Patients who receive 6 mg intracoronary reteplase after thrombosuction, and then stent is embedded. Group 4: Patients after thrombosuction will receive 180 micrograms per kilogram of intravenous bolus eptifibatide, and then receive infusion in 2 microgram per kilogram per minute for 18 hours.
Main outcome variables
coronary blood flow, left ventricular diastolic dysfunction change, ST resolution average, average of EF changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170925036401N1
Registration date: 2017-12-07, 1396/09/16
Registration timing: registered_while_recruiting

Last update: 2017-12-07, 1396/09/16
Update count: 0
Registration date
2017-12-07, 1396/09/16
Registrant information
Name
mostafa zadkamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 6394
Email address
mzadkamali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intracoronary and intravenous Eptifibatide and intracoronary Retaplase on coronary blood flow in patients undergoing PPCI at Dr.Heshmat hospital during 2017-2018 (Randomized clinical trial study)
Public title
effect of eptifibatide and reteplase on primary angioplasty outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ischemic tipic chest pain extending more than 30 min, STelevation more than 1 mm in at least 2 leads with the same name, all patients with STEMI candidate for primary PCI, myocardial infarction not extending more than 12 hours, having life expectancy not less than 6 months, consent for participation in the study, age 18 to 80 years, no evidence for prior myocardial infarction, not having contraindications for reteplase or eptifibatide, not having left bundle branch block, not using GPIIb/IIIa in recent two weeks.
Exclusion criteria:
rescue PCI after thrombolytic therapy, emergency CABG, cardiogenic shock, atrial fibrillation TIMI flow grade 3 in primary angiography(ie, having normal blood flow in coronary arteries) simultaneously presence in another intervention study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
random block
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
the old building of the School of Public Health ,opposite the 17th Shahrivar Hospital, Shahid Siadati Ave,Namjoo Ave ,Rasht Town
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.GUMS.REC.1396.304

Health conditions studied

1

Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
coronary blood flow
Timepoint
before and after primary PCI
Method of measurement
based on angiographic scale TIMI blush grade

Secondary outcomes

1

Description
left ventricular diastolic dysfunction change
Timepoint
before and after angiography
Method of measurement
according to echocardiographic criteria

2

Description
ST resolution average
Timepoint
before and 90 minutes after PCI
Method of measurement
based on electrocardiogram

3

Description
average of EF changes
Timepoint
before and 3 to 4 days after angioplasty
Method of measurement
based on echocardiography

Intervention groups

1

Description
Intervention group: Group 1: Patients who have a stent after thrombosuction.
Category
Treatment - Drugs

2

Description
Intervention group:Group 2: Patients who receive 180 microgram per kilogram of intracoronary bolus eptifibatide by interval of 10 minutes and then stent is embeded.
Category
Treatment - Drugs

3

Description
Intervention group:Group 3: Patients who receive 6 mg of intra-coronary reptal after thrombosis, and then inserted into the stent.
Category
Treatment - Drugs

4

Description
Intervention group: Group 4:Patients after thrombosuction will receive 180 microgram per kilogram of intravenous bolus eptifibatide and then receive 2 microgram per kilogram per minute of infusion over 18 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat heart hospital
Full name of responsible person
dr. mostafa zadkamali
Street address
15 khordad Ave, Next to Gilan Province Management and Planning Organization,Rasht Town
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 9064
Email
mzadkamali@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Shadman Nemati
Street address
the old building of the School of Public Health, opposite the 17th Shahrivar Hospital, Namjoo Ave, Shahid Siadati Ave, Rasht
City
Rsht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 6394
Email
mhoseinie@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mostafa Zadkamali
Position
resident of cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
the old building of the School of Public Health,opposite the 17th Shahrivar Hospital,, Namjoo Ave, Shahid Siadati Ave,Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 6394
Fax
+98 13 3332 6065
Email
mzadkamali@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mostafa Zadkamali
Position
resident of cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Next to Gilan Province Management and Planning Organization, 15 khordad Ave, Rasht
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 9064
Fax
+98 13 3366 8718
Email
mzadkamali@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
mahbubeh Taleb Jannesar Hoseinie
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
15 khordad Ave,Heshmat heart hospital,Rasht
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 9064
Fax
Email
mhoseinie@yahoo.com
Web page address

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
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