Comparing the effect of receiving only bolus dose Eptifibatide with bolus plus infusion strategy on bleeding complications and consequences after Percutaneous Coronary Intervention (PCI) on Myocardial Infarct (MI) patients
Aim of this study: Comparing the effect of only bolus Eptifibatide with bolus plus infusion form of Eptifibatide on bleeding complications after PCI on MI patients
Inclusion criteria: MI patients who are candidate for angioplasty and PCI
Exclusion criteria: having sensitivity toEptifibatide or any contraindication for using this medication
Patients are randomly divided in to two groups. the first group is received 180 mcg/kg Eptifibatide before PCI in bolus form from a peripheral vein during 8 minutes. The second group is received 180 mcg/kg Eptifibatide before PCI in bolus form from peripheral vein during 8 minutes and after PCI they are received infusion of 2 mcg/kg/min Eptifibatide for 10 hours.
After intervention the incidence of bleeding complications and hematoma is evaluated and compared between two groups.
General information
Acronym
No
IRCT registration information
IRCT registration number:IRCT2017071935183N1
Registration date:2017-08-07, 1396/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
hasan shemirani
Name of organization / entity
isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 3407
Email address
shemirani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical science
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of receiving only bolus dose Eptifibatide with bolus plus infusion strategy on bleeding complications and consequences after Percutaneous Coronary Intervention (PCI) on Myocardial Infarct (MI) patients
Public title
Comparing the effect of only bolus Eptifibatide with bolus plus infusion form of Eptifibatide on bleeding complications and consequences on myocardial infarct patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were as followed: 1) age more than 18 years, 2)having elevation in Troponin enzyme level, 3) having electrocardiogram changes due to infarction, 4)candidate for angioplasty and percutaneous coronary intervention, 5) having no contraindication for administrating Eptifibatide, 6) patient's willingness to participate in this study
Exclusion criteria were as followed:1) Patient's unwillingness to continue his/ her participation, 2)history of stroke, 3)treating with anti coagulant medications, 4)using medications that has interaction with Eptifibatide, 5) have not experience PCI, 6)have experienced thrombectomy, 7) having sensitivity to Eptifibatide, 8) having uncontrolled hypertension, 9) dialysis patients
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical science
Street address
isfahan, hezar jarib street, isfahan university of medical sciene
City
isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
395717
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
I21
ICD-10 code description
E1, E2, E3, E4, E9
Primary outcomes
1
Description
incidence of hematoma
Timepoint
immediately after intervention, 24, 48,72 and 96 hours after intervention
Method of measurement
observation
2
Description
incidence of bleeding
Timepoint
immediately after intervention, 24, 48,72 and 96 hours after intervention
Method of measurement
observation
Secondary outcomes
1
Description
needs for additional coronary intervention
Timepoint
one week after intervention
Method of measurement
physical examination
2
Description
death
Timepoint
one week after intervention
Method of measurement
observation
Intervention groups
1
Description
the first group is received a bolus dose of 180 mcg/kg Eptifibatide (Integrilin company)from peripheral vein during 8 minutes, immediately before PCI and after that PCI is done.After PCI. all patients received 75 mg clopidogrel for every 12 hours as a routine treatment.
Category
Treatment - Drugs
2
Description
Patients in the second group received routine treatment in addition with 10-hours infusion of 2 mcg/kg/min Eptifibatide with maximum dose of 15 mcg/hour and if patients creatinine clearance< 50 mg/min, about 1 mcg/kg/min of Eptifibatide were infused and if patients had creatinine>4, they were excluded from study. All patients were received 75 mg clopidogrel every 12 hours as a routine treatment