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IRCT20201123049469N1 IRCT 2020-12-22 Ahvaz University of Medical Sciences Comparison of rivaroxaban and enoxaparin in the prevention of recurrent venous thromboembolism Comparison of rivaroxaban and enoxaparin in the prevention of recurrent venous thromboembolism in patients with nonhematologic cancer 2020-12-21 anticipated 50 Complete https://irct.ir/trial/52509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Permuted block randomization; Randomization unit: Person; Stratified randomization: Not done; Randomization instrument: ŮŚRandom allocation software (Excel); Random sequence generation: Used random blocks, each block containing 4 people and allocated a number from 1 to 6 to each block; Allocation concealment: The randomization process is performed by the study methodology consultant and, clinical researchers are not aware of the randomization process, Blinding description: The type of blindness in our study will be double-blind. Prior to the onset of the study, the box containing the relevant tablets are coded A and B by someone except the researcher, in order to blind the researcher about which drug each group received. When delivering drugs to patients, someone except the researcher should locate the patient in either A or B group by random number table. In this study, the patient, physician, and researcher (who collecting data and assessing the outcome) should be kept blind. 3 Nonhematologic Cancers. Intervention 1: Intervention group: Oral rivaroxaban treatment group, 15 mg every 12 hours for the first three weeks and then 20 mg daily / Axabin; Abidi Company, Tehran. Intervention 2: Intervention group: The dose of enoxaparin (Lovenox; Osweh Pharmacy, Tehran) was 1 mg per kg body weight, but because 60 or 80 mg ampoules were used, depending on the patient's weight, 60 or 80 mg of the drug every 12 hours as the following injection It was prescribed cutaneously. Yes - There is a plan to make this available What will be shared: If the decision is to publicate the data, after the unidentified individuals all data will be publicated. When: The access period will be 8 months after the publication of the results. To whom: Researchers working in academic and industrial institutions can apply to get data. Conditions: To cite. Referring to reference or researcher's permission Where to obtain: Afrooz Kargaran Dehkordi, Resident of Internal Medicine, Imam Khomeini Hospital,Azadegan Ave, Ahvaz./ +98 61 3321 4578/ karegaran.a@ajums.ac.ir How to obtain: Access to articles related to this research Send email to the responsible author Comments:
public Afrooz Kargaran Dehkordi
Imam Khomeini Hospital,Azadegan Ave, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3321 4578 karegaran.a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Afrooz Kargaran Dehkordi
Imam Khomeini Hospital,Azadegan Ave, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3321 4578 karegaran.a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Existence of active cancer with Venous thromboembolism The age range is between 18-75 years Tendency to participate in the study 18 years 75 years Both Smoking, alcohol and drug abuse Lack of sufficient and appropriate evidence for the occurrence of early Venous thromboembolism Diagnosis of thrombophilic conditions Prescribe any anticoagulant drug excepting Enoxaparin or Rivaroxaban (for example Heparin, Warfarin, Dabigatran, Apixaban, and Edoxaban) I74.9 Embolism and thrombosis of unspecified artery Treatment - Drugs Treatment - Drugs Intervention group: Oral rivaroxaban treatment group, 15 mg every 12 hours for the first three weeks and then 20 mg daily / Axabin; Abidi Company, Tehran Intervention group: The dose of enoxaparin (Lovenox; Osweh Pharmacy, Tehran) was 1 mg per kg body weight, but because 60 or 80 mg ampoules were used, depending on the patient's weight, 60 or 80 mg of the drug every 12 hours as the following injection It was prescribed cutaneously. Recurrence of VTE (Venous thromboembolism) is deep vein thromboembolism (DVT) or pulmonary embolism (PE) according to the report of CT scan of the pulmonary arteries and color Doppler ultrasound of the lower extremity to be reported by the radiologist. Timepoint: At the beginning of the study (before the intervention) and 6 months later. Method of measurement: according to the report of CT scan of the pulmonary arteries and color Doppler ultrasound of the lower extremity to be reported by the radiologist. Ahvaz University of Medical Sciences Approved 2019-12-28 Ethics committee of Ahvaz University of Medical Sciences Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)