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IRCT20151227025726N22 IRCT 2020-10-07 Shahid Beheshti University of Medical Sciences Evaluating the efficacy and safety of rivaroxaban comparing to warfarin in patients with chronic thromboembolic pulmonary hypertension (CTEPH) following endartrectomy surgery Evaluating the efficacy and safety of rivaroxaban comparing to warfarin in patients with chronic thromboembolic pulmonary hypertension (CTEPH) following endartrectomy surgery 2019-10-08 anticipated 96 Complete https://irct.ir/trial/51285 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. Using online randomiser website (www.sealedenvelope.com/simple-randomiser/v1/lists), patients were randomised with 1-2 ratio into two groups. 2-3 Chronic Thrombo Embolic Pulmonary Hypertension(CTEPH). Intervention 1: Intervention group: For the intervention group, rivaroxaban was prescribed at a dose of 15 mg twice a day for 21 days and then 20 mg once a day.In the study, Rivaoxaban made by Dr. Abidi Pharmaceutical Company under the brand name Xalerban will be used. Intervention 2: Control group: Apotex warfarin tablet will be prescribed based on patients INR goal of 2-3. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six months after publishing the results To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers Comments:
public Hossein Amini Ebrahimabad
Shahid Beheshti School of Pharmacy, No 2660, Niayesh intersection, Valiasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Hosseinamini96@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzaneh dastan
Shahid Beheshti School of Pharmacy, No 2660, Niayesh intersection, Valiasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 F_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients undergoing endarterectomy following chronic thromboembolic pulmonary hypertension at Masih Daneshvari Hospital. 18 years 80 years Both Any allergies to the prescribed medication Any bleeding includes active gastrointestinal, pulmonary, genitourinary bleeding Cerebral aneurysm Intracranial bleeding Aneurysm and aortic dissection A patient undergoing spinal puncture Blood dyscrasia Uncontrolled blood pressure (110/180 mmHg <pressure) Inflammation and pericardial effusion Bacterial endocarditis Pregnancy and lactation Liver disease(child pugh B&C) GFR<30 mL/min Any coagulation disorder If the patient has been prescribed strong Cyp450 and Pgp inhibitors such as ketoconazole, itraconazole, posaconazole and ritonavir. I27. 24 Chronic Thromboembolic Pulmonary Hypertension. Treatment - Drugs Treatment - Drugs Intervention group: For the intervention group, rivaroxaban was prescribed at a dose of 15 mg twice a day for 21 days and then 20 mg once a day.In the study, Rivaoxaban made by Dr. Abidi Pharmaceutical Company under the brand name Xalerban will be used. Control group: Apotex warfarin tablet will be prescribed based on patients INR goal of 2-3. Recurrence of thrombosis. Timepoint: Patients are evaluated at one, three and six months after surgery. Method of measurement: Medical record. Incidence of ischemic and hemorrhagic stroke. Timepoint: Patients are evaluated at one, three and six months after surgery. Method of measurement: Medical record. Incidence of bleeding. Timepoint: Patients are evaluated at intervals of one, three and six months after surgery. Method of measurement: Medical record. Patient readmission. Timepoint: Patients are evaluated at intervals of one, three and six months after surgery. Method of measurement: Medical record. Shahid Beheshti University of Medical Sciences Approved 2019-10-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti School of Pharmacy, No 2660, Niayesh intersection, Valiasr St. Tehran Tehran Iran (Islamic Republic of)