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IRCT20220809055645N4 IRCT 2023-05-23 Rasht University of Medical Sciences Effect of heparin and enoxaparin in patients undergoing primary angioplasty Comparison of efficacy and safety of Heparin and Enoxaparin versus control group in patients undergoing primary percutaneous intervention: An open labelled randomized clinical trial 2023-05-22 anticipated 171 Complete https://irct.ir/trial/70091 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of sampling and randomization will be the blocked randomization method. In this way, each person will be randomly assigned to the intervention or control groups using blocks of size 6 in a ratio of 1:1:1. The website http://www.randomization.com/ will be used for randomization. The list of codes obtained from this website will be provided to project researchers, and every patient with acute myocardial infarction who met the inclusion criteria will be entered into the project based on the assigned code A, B, and C, respectively. In this research, simple random allocation concealment method will be used. In this way, each patient will be assigned a code. In this method, each of the generated random codes will be written on a card. Then they will be placed inside sealed opaque envelopes in random order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lid of the letter envelopes will be glued and will be placed in a box respectively. At the time of sampling, based on the order of entry of qualified participants into the study, one of the envelopes will be revealed in the order of opening and the assigned group of that participant. 3 Acute myocardial infarction. Intervention 1: Intervention group: The first intervention group includes 57 patients with myocardial infarction who will undergo percutaneous coronary intervention (PCI). These patients will enter the study with their personal consent and after completing the informed consent form. For the participants in the first intervention group, from three hours after removing the sheet until the end of hospitalization, unfractionated heparin 60 U/kg bolus and then 12 U/kg/h will be administered as an infusion. Intervention 2: Intervention group: In the second intervention group, 57 participants will be treated with enoxaparin (LMWH) 1 mg/kg twice a day (once every 12 hours) from three hours after removing the sheet until the end of hospitalization. It should be noted that all these interventions will end after the patient is discharged from the hospital. Intervention 3: Control group: It includes 57 patients with myocardial infarction who will undergo percutaneous coronary intervention (PCI). These patients will enter the study with their personal consent and after completing the informed consent form. Participants in the control group will not receive any injectable anticoagulant from three hours after removing the sheet until the end of their hospitalization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known
public Fatemeh Baharvand
Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15 Khordad Street, Mosalla Square
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 dr.baharcardio@gmail.com Rasht University of Medical Sciences scientific Fatemeh Baharvand
Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15 Khordad Street, Mosalla Square
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 dr.baharcardio@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Myocardial infarction with ST segment elevation 18 years 65 years Both Having coagulopathy Having no consent to participate in the study and follow-up courses Having underlying bleeding disorders, mechanical valve history Presence of other indications for receiving anticoagulants Absolute prohibition of receiving anticoagulants (such as active bleeding at the time of visit, drug sensitivity) GFR lower than 30 liver failure I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first intervention group includes 57 patients with myocardial infarction who will undergo percutaneous coronary intervention (PCI). These patients will enter the study with their personal consent and after completing the informed consent form. For the participants in the first intervention group, from three hours after removing the sheet until the end of hospitalization, unfractionated heparin 60 U/kg bolus and then 12 U/kg/h will be administered as an infusion. Intervention group: In the second intervention group, 57 participants will be treated with enoxaparin (LMWH) 1 mg/kg twice a day (once every 12 hours) from three hours after removing the sheet until the end of hospitalization. It should be noted that all these interventions will end after the patient is discharged from the hospital. Control group: It includes 57 patients with myocardial infarction who will undergo percutaneous coronary intervention (PCI). These patients will enter the study with their personal consent and after completing the informed consent form. Participants in the control group will not receive any injectable anticoagulant from three hours after removing the sheet until the end of their hospitalization. Incidence of stroke. Timepoint: 40 days after primary angioplasty. Method of measurement: By using clinical documents of patients and asking them. Cardiac death. Timepoint: 40 days after primary angioplasty. Method of measurement: By using clinical documents of patients. Recurrent myocardial infarction. Timepoint: 40 days after primary angioplasty. Method of measurement: By using clinical documents of patients. Mean ejection fraction of the left ventricle. Timepoint: 40 days after primary angioplasty. Method of measurement: Echocardiography. Rasht University of Medical Sciences Approved 2023-05-03 Ethics committee of Guilan University of Medical Sciences Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15 Khordad Street, Mosalla Square Rasht Guilan Iran (Islamic Republic of)