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IRCT20110512006463N3 IRCT 2021-03-17 Deputy of research and technology of Alborz University of Medical Sciences Bolus eptifibatide versus bolus plus infusion A comparison of complication & major cardiovascular events of bolus eptifibatide versus bolus plus infusion of eptifibatide in Primary PCI in patients with acute ST-elevation myocardial infarction 2018-04-01 anticipated 163 Complete https://irct.ir/trial/30301 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was done using the website of: "https://www.sealedenvelope.com/simple-randomiser/v1/lists" The treatment group was put in pockets to be used during the study and the study group was determined according to the content of pockets, Blinding description: For blinding, the control group received normal saline as the placebo with the same volume and time duration as the intervention group. Patients are blinded to the received medication. The outcome assessor will be blinded to the treatment allocation group. 3 Condition 1: Acute ST elevation myocardial infarction. Condition 2: Acute ST elevation myocardial infarction. Condition 3: Acute ST elevation myocardial infarction. Condition 4: Acute ST elevation myocardial infarction. Intervention 1: Intervention group will receive 2 bolus doses of eptifibatide (Merk) with dose of 180mcg/kg with 10 minute interval. Then they will receive 2mcg/kg/min of eptifibatide infusion; totally 1 vial of 75mg/cc (short term protocol). Intervention 2: Control group: will receive 2 bolus doses of eptifibatide (Merk) with a dose of 180mcg/kg with a 10-minute intervals. Then they will receive normal saline as the placebo with the same volume and time duration as the intervention group. Yes - There is a plan to make this available What will be shared: Data after deidentification When: After publishing the article To whom: Investigatores Conditions: Email to correspounding author Where to obtain: Corresponding author How to obtain: Email Comments:
public Dr. Fatemeh Sehati
R and D unit, Shahid Rajaei Hospital, Shahid Rajaei Ave, Karaj, Iran
Karaj Iran (Islamic Republic of) 3197635141 +98 26 3457 0030 F_sehati@yahoo.com ِAlborz University of Medical Sciences scientific Dr.Fatemeh Sehati
R and D unit, Shahid Rajaei Hospital, Shahid Rajai Ave, Karaj, Iran
Karaj Iran (Islamic Republic of) 3197635141 +98 26 3457 0030 f_sehati@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) Patients with symptoms of ischemic heart attack that last no longer than 12 hours with 1 mm ST elevation in at least 2 limb leads or 2 mm ST elevation in at least 2 precordial leads who are candidates for Primary PCI intervention. 18 years no limit Both Not acceptance of informed consent History of sensitivity to eptifibatide, heparin or aspirin Recent treatment with warfarin (INR>2), fibrinolythics or other IIbIIIa inhibitors Platelet <100000/mcL Known bleeding disorder History of ischemic cerebrovascular accident in previous 30 days History of hemorrhagic cerebrovascular accident Abnormal bleeding in recent 30 days. Major surgery in previous 6 weeks Renal failure with dependency to hemodialysis Uncontrolled hypertension (SBP>200mmHg, or DBP>110mmHg) I21.3 I21.0 I21.1 I21.2 ST elevation (STEMI) myocardial infarction of unspecified site ST elevation (STEMI) myocardial infarction of anterior wall ST elevation (STEMI) myocardial infarction of inferior wall ST elevation (STEMI) myocardial infarction of other sites Treatment - Drugs Treatment - Drugs Intervention group will receive 2 bolus doses of eptifibatide (Merk) with dose of 180mcg/kg with 10 minute interval. Then they will receive 2mcg/kg/min of eptifibatide infusion; totally 1 vial of 75mg/cc (short term protocol) Control group: will receive 2 bolus doses of eptifibatide (Merk) with a dose of 180mcg/kg with a 10-minute intervals. Then they will receive normal saline as the placebo with the same volume and time duration as the intervention group. Vascular or bleeding complication. Timepoint: During in-hospital admision. Method of measurement: Questionnaire and physical exam. Death. Timepoint: 2 days and 6 months after intervention. Method of measurement: Questionnaire, Electronic file. Myocardial infarction. Timepoint: 2 days and 6 months after intervention. Method of measurement: ECG and increase in CKMB. Need for target lesion revascularization (TLR). Timepoint: 2 days and 6 months after intervention. Method of measurement: Questionnaire, Electronic file. Need for target vessel revascularization (TVR). Timepoint: 2 days and 6 months after intervention. Method of measurement: Questionnaire, Electronic file. Need for coronary artery bypass graft (CABG). Timepoint: 2 days and 6 months after intervention. Method of measurement: Questionnaire, Electronic file. Cerebrovascular accidents. Timepoint: 2 days and 6 months after intervention. Method of measurement: Questionnaire, Electronic file. Deputy of research and technology of Alborz University of Medical Sciences Approved 2020-10-10 Ethics Committee of Alborz Medical School Alborz university of medical sciences- North Taleghani Blvd, Karaj, Iran karaj Alborz Iran (Islamic Republic of)