]>
IRCT20210614051574N9 IRCT 2022-02-19 Esfahan University of Medical Sciences Treatment with rivaroxaban compared with warfarin in patients with acute coronary syndrome Evaluation of the effect of rivaroxaban treatment in comparison with warfarin on the resolution, size, mobility and morphology of left ventricular apical thrombus and also comparing the incidence of bleeding, readmission, embolic events and cardiovascular events in patients with acute coronary syndrome 2022-03-03 anticipated 60 Complete https://irct.ir/trial/60691 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Acute coronary syndrome. Intervention 1: Intervention group 1: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, rivaroxaban 15 mg tablets from Abureyhan Company will be used every 12 hours for 21 days and then 20 mg daily. Resolution, size, mobility and morphology of left ventricular apical thrombus by echocardiography as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated. Intervention 2: Intervention group 2: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, 5 mg warfarin tablets from Abureyhan Company will be used daily to maintain the INR between 2 and 3. Resolution, size, mobility and morphology of left ventricular apical thrombus by echocardiography as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results. To whom: Academic researchers Conditions: Scientific uses Where to obtain: Website of the Research Committee of Isfahan University of Medical Sciences How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Mohammad Hadi Mansouri
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 parsa.alinezhad85@gmail.com Esfahan University of Medical Sciences scientific Mohammad Hadi Mansouri
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 parsa.alinezhad85@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Acute coronary syndrome Treated with aspirin and Plavix 18 years no limit Both Renal and hepatic failure Existence of contraindications to anticoagulant therapy Major trauma Uncontrolled hypertension I24 Other acute ischemic heart diseases Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, rivaroxaban 15 mg tablets from Abureyhan Company will be used every 12 hours for 21 days and then 20 mg daily. Resolution, size, mobility and morphology of left ventricular apical thrombus by echocardiography as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated. Intervention group 2: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, 5 mg warfarin tablets from Abureyhan Company will be used daily to maintain the INR between 2 and 3. Resolution, size, mobility and morphology of left ventricular apical thrombus by echocardiography as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated. Left ventricular morphology information. Timepoint: 3 months after starting the study. Method of measurement: Eco cardiography. Bleeding. Timepoint: 3 months after starting the study. Method of measurement: Review the case and follow up with the patient. Esfahan University of Medical Sciences Approved 2020-11-10 Ethics committee of Esfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan Isfahan Isfehan Iran (Islamic Republic of)