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IRCT20220404054402N1 IRCT 2022-06-10 Ahvaz University of Medical Sciences Evaluation of the effectiveness of with different types of anticoagulants treatment in patients with atrial fibrillation in one-year follow-up in preventing stroke and bleeding complications Evaluation of the effectiveness of with different types of anticoagulants treatment in patients with atrial fibrillation in one-year follow-up in preventing stroke and bleeding complications comparison of drugs warfarin rivaroxaban and apixaban 2022-06-21 anticipated 198 Complete https://irct.ir/trial/62882 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be performed using block randomization of 3 blocks in 3 groups including group A (Rivaroxaban), group B (Apixaban) and group C (Warfarin). According to the sample size, the number of these blocks is 66 (198/3). The block randomization are done by random number table at the beginning of the study and stored in a sealed envelope. After the research approval, the blocks will be taken out daily based on the patients' referrals through a person who is not in the study. Patients receive the desired drugs based on block permutation, Blinding description: This is a double-blind randomized clinical trial in which neither the data analyst nor the person who is evaluating the outcomes knows which type of drugs patients are receiving until the end of the study . 2 Atrial fibrillation. Intervention 1: Intervention group: 15-20 mg oral rivaroxaban once daily for 1 year (Arena Hayat Danesh company). Intervention 2: Intervention group: 2.5-5 mg oral apixaban twice daily for 1 year (Arena Hayat Danesh company). Intervention 3: Intervention group: 5 mg oral warfarin once daily for 1 year (Dr.Abidi pharmaceutical company). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Zahra Khademi
Esfand Ave., Golestan Blvd ., Ahvaz., Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 3477 zahrakhademi157@gmail.com Ahvaz University of Medical Sciences scientific Zahra Khademi
Esfand Ave., Golestan Blvd ., Ahvaz., Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 3477 zahrakhademi157@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age > 18 years Diagnosis of atrial fibrillation Informed consent to participate in the study Elevated CHA2DS2-VASc score of 2 or greater in men or 3 or greater in women 18 years no limit Both Patients treated with multiple oral anticoagulants Taking multiple doses of the drug Taking drugs with indications other than prevention of stroke and hemorrhage Loss to follow-up before 1 year Patients without comorbidity known to be associated with higher mortality such as heart failure, cancer, chronic pulmonary disease I48.2 Chronic atrial fibrillation Prevention Prevention Prevention Intervention group: 15-20 mg oral rivaroxaban once daily for 1 year (Arena Hayat Danesh company) Intervention group: 2.5-5 mg oral apixaban twice daily for 1 year (Arena Hayat Danesh company) Intervention group: 5 mg oral warfarin once daily for 1 year (Dr.Abidi pharmaceutical company) Minor and major bleeding. Timepoint: First after 6 months after 12 months. Method of measurement: Physical exam,Hemoglobin,Pletlet and Coagulation test. Ischemic stroke and Systemic embolism. Timepoint: First after 6 months after 12 months. Method of measurement: Physical exam. Ahvaz University of Medical Sciences Approved 2022-02-01 Ethics committee of Golestan hospital Farvardin Ave ., Ahvaz ., Iran Ahvaz Khouzestan Iran (Islamic Republic of)