Comparison of efficacy and safety of Heparin and Enoxaparin versus control group in patients undergoing primary percutaneous intervention: An open labelled randomized clinical trial

Determining and comparing the efficacy and safety of heparin and enoxaparin with the control group in patients undergoing primary angioplasty

A controlled, parallel-group, open-label, randomized clinical trial on 171 patients. The website http://www.randomization.com/ will be used for randomization.

In this open label, clinical trial study, patients aged 18 to 65 years with acute myocardial infarction with ST segment elevation, who will undergo primary PCI in the emergency room of Dr. Heshmat Rasht Hospital in the period of 2023-2024, in the service of an international cardiologist will enter the study. According to inclusion and exclusion criteria,all these patients will be included in the study after completing the informed consent form. The current clinical trial has one control and two intervention groups.

Inclusion criteria:myocardial infarction with ST segment elevation. Non-inclusion criteria: having coagulopathy, underlying bleeding disorders, history of mechanical valve, presence of other indications for receiving anticoagulants, absolute prohibition of receiving anticoagulants, GFR lower than 30 and liver failure

The control group includes patients with myocardial infarction who will not receive any injectable anticoagulant from three hours after the sheet removal until the end of the hospitalization period. In the first intervention group, 60 U/kg bolus of unfractionated heparin and then 12 U/kg/h as an infusion will be prescribed from three hours after sheet removal until the end of hospitalization. In the second intervention group, they will be treated with enoxaparin (LMWH) 1 mg/kg twice a day (once every 12 hours) from three hours after sheet removal until the end of the hospitalization period.

Stroke, cardiac death and recurrent myocardial infarction in the first 40 days after discharge from the hospital

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.