Comparison of the efficacy of intracoronary and intravenous Eptifibatide and intracoronary Retaplase in thrombus aspiration in patients undergoing Primary percutaneous coronary interventions (PPCI); Randomized clinical trial study)
Deputy of Research of Guilan University of Medical Sciences
Expected recruitment start date
2017-11-21, 1396/08/30
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 in thrombus aspiration in patients undergoing Primary percutaneous coronary interventions (PPCI); Randomized clinical trial study)
Public title
effect of eptifibatide and reteplase on primary angioplasty outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:
Ischemic typical chest pain extending more than 30 min;
ST elevation 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:
Exclusion criteria:
Rescue PCI after thrombolytic therapy;
emergency CABG;
AF;
cardiogenic shock;
TIMI flow grade 3 in primary angiography
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research of Guilan University of Medical Sciences
Street address
Rasht, Namjoo Ave., Shahid Siadati Avenue, opposite the 17th Shahrivar Hospital, the old building of the School of Public Health
City
Rasht
Postal code
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
I21
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
All patients will receive Emergency PCI treatment. Patients will receive 300 mg of chewing aspirin and 600 mg of Clopidogrel maintenance dose prior to the procedure before transferring to the catheterism room. In the first group, the patients undergo thrombus suction after the wiring , and then the stent is embedded.In the second group, the patients undergo thrombus suction after wiring , then receive 180μg / kg intra coronary bolus eptifibatide. Intra coronary eptifibatide will be injected 2 times with 10 minutes interval and then the stent will be embedded.In the third group, patients undergo thrombus suction after wiring , and then 6 mg intracoronary reteplase is injected and the stent will be embedded.In the fourth group, the patients undergo thrombus suction after wiring , then receive 180μg / kg intravenous bolus eptifibatide during 18 hours in the ward.After the procedure angiography report for TIMI blush grade and corrected TIMI frame count will be seen.All patients will be treated with a maintenance dose of 75 mg clopidogrel daily for one year and 300 mg of aspirin for 30 days and then 100 mg.
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
Rasht- 15 khordad street- Next to Gilan Province Management and Planning Organization
City
Rsht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Guilan University of Medical Sciences
Full name of responsible person
dr.shadman nemati
Street address
Rasht, Namjoo Ave., Shahid Siadati Avenue, opposite the 17th Shahrivar Hospital, the old building of the School of Public Health
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Guilan 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
Guilan University of medical sciences
Full name of responsible person
Mostafa Zadkamali
Position
resident of cardiology
Other areas of specialty/work
Street address
Rasht- parastar street- Headquarters building of Guilan University of Medical Sciences