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IRCT20220809055645N1 IRCT 2022-08-13 Rasht University of Medical Sciences Comparing the efficacy and safety of apixaban compared to warfarin in patients with left ventricular thrombosis after acute myocardial infarction Effectiveness and safety of Apixaban versus Warfarin in patients with left ventricular thrombus following acute myocardial infarction: A randomized clinical trial 2022-08-23 anticipated 104 Complete https://irct.ir/trial/65221 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Left ventricular thrombosis following acute myocardial infarction. Intervention 1: Intervention group: Including 52 patients with left ventricular thrombosis after myocardial infarction who will enter the study with personal consent and after completing the informed consent form. Apixaban anticoagulant will be prescribed for the participants in the intervention group. In this way, the patients of this group will take apixaban 5 mg twice a day, from the time the left ventricular thrombosis is seen until the end of the study, that is, up to three months after the start of the intervention. 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. Intervention 2: Control group: It will include 52 patients with left ventricular thrombosis caused by myocardial infarction, who will enter the study with personal consent and after completing the informed consent form. Warfarin will be prescribed for the participants in the control group. In this way, the patients of the control group will be asked to take warfarin 5 mg once a day. In the control group (warfarin user group), patients are treated with combined low molecular weight heparin (LMWH) and warfarin for at least 5 days as soon as left ventricular thrombosis is diagnosed. Whenever the patient's INR is in the therapeutic range (2-3) for at least 3 days, LMWH will be stopped and warfarin alone will be continued. It should be noted that warfarin dose adjustment in the group receiving warfarin is based on the INR level of the patients and this INR should be maintained throughout the study. Therefore, at any stage of the study, if the patient's INR is outside the normal range of 2 to 3, the patient will be excluded from the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patients' information will be kept confidential and it will be only available to this project's researchers.
public Fatemeh Baharvand
Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran
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, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 dr.baharcardio@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) All patients with left ventricular thrombosis within two weeks after acute myocardial infarction, if there is no contraindication to the use of anticoagulants no limit no limit Both 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.) I23.6 Thrombosis of atrium, auricular appendage, and ventricle as current complications following acute myocardial infarction Treatment - Drugs Treatment - Drugs Intervention group: Including 52 patients with left ventricular thrombosis after myocardial infarction who will enter the study with personal consent and after completing the informed consent form. Apixaban anticoagulant will be prescribed for the participants in the intervention group. In this way, the patients of this group will take apixaban 5 mg twice a day, from the time the left ventricular thrombosis is seen until the end of the study, that is, up to three months after the start of the intervention. 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. Control group: It will include 52 patients with left ventricular thrombosis caused by myocardial infarction, who will enter the study with personal consent and after completing the informed consent form. Warfarin will be prescribed for the participants in the control group. In this way, the patients of the control group will be asked to take warfarin 5 mg once a day. In the control group (warfarin user group), patients are treated with combined low molecular weight heparin (LMWH) and warfarin for at least 5 days as soon as left ventricular thrombosis is diagnosed. Whenever the patient's INR is in the therapeutic range (2-3) for at least 3 days, LMWH will be stopped and warfarin alone will be continued. It should be noted that warfarin dose adjustment in the group receiving warfarin is based on the INR level of the patients and this INR should be maintained throughout the study. Therefore, at any stage of the study, if the patient's INR is outside the normal range of 2 to 3, the patient will be excluded from the study. Reduction of thrombosis and bleeding in patients with left ventricular thrombosis after acute myocardial infarction. Timepoint: At the beginning of the study, 3 months after the intervention. Method of measurement: By Echocardiography. Elimination of thrombus or change in size and its organization in the three-month follow-up, reduction of stroke and other thromboembolic events. Timepoint: Three months after the intervention. Method of measurement: By Echocardiography. Rasht University of Medical Sciences Approved 2022-07-13 Ethics committee of Guilan University of Medical Sciences Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)