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IRCT20150621022852N4 IRCT 2019-02-27 Shahid Beheshti University of Medical Sciences Evaluation of the effects of Rosuvastatin in the treatment of patients with deep vein thrombosis(DVT) Study of the effects of Rosuvastatin in the treatment of patients with acute deep vein thrombosis(DVT) of lower extremities 2017-05-22 anticipated 50 Complete https://irct.ir/trial/37442 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: This blindness study was conducted on clinical outcomes evaluators. Clinical outcomes evaluated only patients at the end of the study and did not play any role in initiating and tracking patients. 3 Deep Vein Thrombosis. Intervention 1: Control group: Patients are being treated with warfarin. Drug daily intake of 5 to 10 mg with the goal of maintaining an INR level of 2-3. Intervention 2: Intervention group: Rivaroxaban group. The dose was 15 mg daily BD daily and then 20 mg daily for the first 3 weeks. Intervention 3: Intervention group: Warfarin + Resostatin. Warfarin usage similar to the control group plus 20 mg of rosuvastatin daily. Intervention 4: Intervention group: Rivaroxaban + Rosuvastatin. The rivaroxaban dose was 15 mg daily BD daily, followed by 20 mg daily, plus daily 20 mg of rosuvastatin. Yes - There is a plan to make this available What will be shared: All information about the outcome of the study, will be available after concealment. When: One year after the publication of the study results To whom: Researchers and university students of related fields can access the data after passing the administrative process. Conditions: A study observer appointed by the ethics committee of Shahid Beheshti University of Medical Sciences can request to receive data after being unidentifiable in order to control the ethical aspects of the study. Where to obtain: Head of the Center for Development of Clinical Research - Management of Shohada Tajrish Hospital How to obtain: To receive data, please contact the Shohada Tajrish HospitalClinical Development Center. After obtaining permission from the Head of the Research Center and then the Shohada Tajrish Hospital, access to patient information and study will be provided. Comments:
public Dr. Mehdi Pishgahi
Shohada Tajrsih Hosptal,Tajrish sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 M.pishgahi@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Mehdi Pishgahi
Shohada Tajrish Hospital,Tajrish sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 M.pishgahi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All patients with unilateral Deep Vein thrombosis of the lower extremities. 18 years 80 years Both Patients with ESRD who underwent regular dialysis and patients with CRF who had GFR below 1.73 m2.mL / min Patients need any invasive intervention in the treatment of DVT. The patient with any illness, including infection and sepsis, which can interfere with the level of inflammatory factors and D-dimer. Patients with history of active malignancy. Bilateral lower limb DVT I80.2 Phlebitis and thrombophlebitis of other deep vessels of lower extremities Prevention Prevention Prevention Prevention Control group: Patients are being treated with warfarin. Drug daily intake of 5 to 10 mg with the goal of maintaining an INR level of 2-3. Intervention group: Rivaroxaban group. The dose was 15 mg daily BD daily and then 20 mg daily for the first 3 weeks. Intervention group: Warfarin + Resostatin. Warfarin usage similar to the control group plus 20 mg of rosuvastatin daily Intervention group: Rivaroxaban + Rosuvastatin. The rivaroxaban dose was 15 mg daily BD daily, followed by 20 mg daily, plus daily 20 mg of rosuvastatin. The incidence of post thrombotic phlebitis syndrome. Timepoint: After three months from the start of the study. Method of measurement: Based on clinical criteria according to Brandjes questionnaire. Serum levels of C-reactive protein, D-Dimer, as well as lower limb size. Timepoint: At the end of the third month of study. Method of measurement: Using serum samples to measure serum CRP and D-dimer levels, as well as instrumentation for measuring lower limb size. Shahid Beheshti University of Medical Sciences Approved 2017-12-19 Ethics Committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUM, Arabi Ave, Daneshjoo Blvd, Velenjak, Teharn Tehran Iran (Islamic Republic of)