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IRCT20170530034232N2 IRCT 2019-10-01 Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences Outcomes of Warfarin and Rivaroxaban (Xalerban) consumption in patients with Atrial fibrillation Comparing the outcomes of Warfarin consumption compared to Rivaroxaban (Xalerban) in patients with Atrial fibrillation 2019-10-22 anticipated 330 Complete https://irct.ir/trial/42299 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: According to the gradual referral of patients to Dr. Heshmat educational and remedial hospital in Rasht, if they meet the inclusion criteria, randomization is planned to be performed using quadruple-block random allocation method in two groups, group A (Warfarin users) and group B (Xalerban users). According to the sample size, the numbers of these blocks are 83, which were selected by lottery at the beginning of the study, stored in a sealed envelope at Healthy Heart Research Center. After the approval of the research plan and starting the study, the selected blocks will be read out daily by a person who is not involved in the study, according to the patient referrals. Then patients will received the drugs based on block’s permutation. 4 Atrial fibrillation. Intervention 1: Intervention group: After random allocation, 165 patients with atrial fibrillation will take one tablet of Rivaroxaban (Xalerban) 20 mg orally, produced by Abidi pharmaceutical company between meal daily for 6 month. Intervention 2: Control group: After random allocation, 165 patients with atrial fibrillation will take Warfarin produced by Orion corporation pharmaceutical company. The drug dosage will be determined by the physician according to the condition of each patient. Yes - There is a plan to make this available What will be shared: The SPSS file contains all demographic information (age, sex and body mass index), liver's enzyme information and coagulation tests, and side effects of anticoagulants including: skin complications (ecchymosis and hematoma), gastrointestinal complications (constipation, diarrhea, abdominal pain and nausea). Neurological complications (headache and dizziness), fever, fatigue, edema, pain and muscle spasm, risk of bleeding, TIA and CVA When: 6 month after the results are published, the access period will be start. To whom: Researchers working in academic and scientific institutions. Conditions: To obtain new results, researchers will be permitted to use further analysis and the data in the future researches. Where to obtain: Healthy Heart Research Center, Dr Heshmat heart hospital, Mosalla Square, Rasht, Guilan, Iran Phone number: 00981333664282 P.O.Box: 41939-55588 How to obtain: A written request with sufficient detail should be sent to the postal address.After receiving the request, the scientific correspondence author will be responsive within one week. Comments:
public Dr. Jalal Kheirkhah
Healthy Heart Research Center, Heshmat Heart Hospital, Mosalla square, Rasht
Rasht Iran (Islamic Republic of) 41939-55588 +98 13 3366 4282 kheirkhah_jalal@yahoo.com Healthy Heart Research Center of Guilan University of Medical Sciences scientific Dr. Jalal Kheirkhah
Healthy Heart Research Center, Heshmat heart hospital, Mosalla square, Rasht
Rasht Iran (Islamic Republic of) 41939-55588 +98 13 3366 4282 kheirkhah_jalal@yahoo.com Healthy Heart Research Center of Guilan University of Medical Sciences Iran (Islamic Republic of) Being over 50 years old Patients with Atrial fibrillation CHAD2S2 Vasc Score more than 1 50 years no limit Both Patient's dissatisfaction with the study Wolff Parkinson White Syndrome Allergic to any of the drugs Rivaroxaban (Xalerban) and warfarin Abnormal Creatinine level Thrombocytopenia I48.2 Chronic atrial fibrillation Prevention Prevention Intervention group: After random allocation, 165 patients with atrial fibrillation will take one tablet of Rivaroxaban (Xalerban) 20 mg orally, produced by Abidi pharmaceutical company between meal daily for 6 month. Control group: After random allocation, 165 patients with atrial fibrillation will take Warfarin produced by Orion corporation pharmaceutical company. The drug dosage will be determined by the physician according to the condition of each patient. Bleeding. Timepoint: All patients will be followed up by researchers every 15 days in the first month and then every month for 6 month. Method of measurement: Measurement of coagulation factors and hemoglobin level by blood test. Changes in liver's enzymes. Timepoint: All patients will be followed up by researchers every 15 days in the first month and then every month for 6 month. Method of measurement: Measurement of liver's enzymes (SGOT, SGPT) by blood test. Dr. Abidi Pharmaceutical Company Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences Dr. Abidi Pharmaceutical Company Approved 2019-09-07 Ethics committee of Guilan University of Medical Sciences Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences, infront of 17 Shahrivar hospital, Shahid Siadati street, Namjoo street, Rasht Rasht Guilan Iran (Islamic Republic of)