Effectiveness and safety of Apixaban versus Warfarin in patients with left ventricular thrombus following acute myocardial infarction: A randomized clinical trial

Reducing the risk of bleeding in patients and providing newer and more effective solutions to doctors in managing different spectrums of myocardial infarction patients

Clinical trial with a control group, with parallel group, double-blind, randomized, phase 2-3 on 104 patients. The stratified block randomization method will be used for randomization.

This study will be conducted in Dr. Heshmat Hospital in Rasht. This study will be double-blinded, in which participants and outcome assessors will be blinded.

Inclusion: All patients with left ventricular thrombosis within two weeks after acute myocardial infarction, if they do not have contraindications to the use of anticoagulants. Exclusion: History of active bleeding, History of coagulation disorders, Contraindications to Apixaban or warfarin (For example, in patients with ESRD), Drug sensitivity to Apixaban or warfarin, Moderate to severe mitral stenosis, Mechanical valve disease, GFR less than 25, If INR is not within the control-normal range, i.e. 2 to 3, Consumption of drugs which interfere with Apixaban (such as amiodarone, antifungal drugs, anti-AIDS drugs, etc.)

Including 52 patients with left ventricular thrombosis caused by myocardial infarction, for whom apixaban will be prescribed. In this way, the patients of this group will take 5 mg of apixaban twice a day. If the patient has two of the three conditions: weight less than 60 kg, age more than 80 years, and creatinine above 1.5, instead of 5 mg apixaban, he will receive a dose of 2.5 mg.

Reduction of thrombosis and bleeding in patients with left ventricular thrombosis following acute myocardial infarction

The method of sampling and randomization of this clinical trial study will be stratified blocked randomization. In this way, each person was randomly assigned to the intervention or control group using 4 random blocks in a ratio of 1:1. In this method, one of the letters A or B will be assigned to each group.

For the purpose of blinding in this study, the desired drugs, i.e. Apixaban and Warfarin, will be purchased with the budget of the project. Then they will be transferred to identical cans in terms of shape and color. There will be no name or sign of the drugs on the cans. And they will be coded only with A and B. To preserve the properties of medicines, we will put them in dark cans (not glass) and away from light. The doctor who prescribes anticoagulant drugs will be the drug allocator in this plan, who will randomly assign cans A or B to patients. It should be noted that the prescribing physician is not blinded in this study. None of the patients in the plan will know what anticoagulant they are being treated with, and as a result, the study subjects will be blinded. In addition, the physician evaluating the results, who is the one who examines the size change and disappearance of left ventricular thrombus, in this study does not know which patient has received which drug and which group he is in. The same doctor will also check the patient's tests. Therefore, the echocardiography fellowship partner of the project in this study will evaluate the consequences of the use of prescribed anticoagulants by performing echocardiography, and he also does not know what kind of medicine the patient was treated with. Therefore, the co-evaluator of this study will also be blind. As a result, this study will be conducted in a double-blind manner.

Patients' information will be kept confidential and it will be only available to this project's researchers.