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IRCT20210416050990N1 IRCT 2021-04-24 Shahid Beheshti University of Medical Sciences The assessment of effect of Rosuvastatin use in venous thromboembolism - The assessment of effect of Rosuvastatin use on reduce of inflammatory markers in patients with venous thromboembolism 2021-04-26 anticipated 220 Complete https://irct.ir/trial/55647 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Recruited patients are randomly allocated to either intervention or control arm. Both arms are in equal size. Randomization sequence is generated by Random Allocation Software version 1.0 May 2004, using a simple random method. It generates a randomization code for each participant (individual randomization). Randomization is run just one time at the beginning of the study. Then participants’ crossover based on the first randomized allocation. Sequentially numbered sealed opaque envelops are used to conceal the allocation. Each participant receives one envelope containing the randomization code. 3 Venous thromboembolism includes deep vein thrombosis and pulmonary embolism. Intervention 1: Intervention group: In addition to the standard treatment of venous thromboembolism, from the first day of treatment, they receive rosuvastatin 10 mg dose from Dr. Abidi company, one tablet daily for 3 months. Intervention 2: Control group: They receive standard treatment for venous thromboembolism (anticoagulants only). 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 We have not yet reached the final result (for publication) with other collaborators in the project
public Toktam Alirezaei
Tajrish S.Q. , Tajrish Hospital
،ehran Iran (Islamic Republic of) 1989934148 009822712188 alirezaei.toktam@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Toktam Alirezaei
ShohadaTajrish hospital
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 2188 alirezaei.toktam@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients with venous thromboembolism In the age range of 20-75 years 20 years 75 years Both History of inflammatory disease such as antiphospholipid syndrom History of hematologic disorders that influence on lymphocyte, neutrophil and platetet History of regular use of anticoagulant drugs ( valvular heart disease..) or use of anticoagulant in recent one year Use of statins or fibrate or ezetymab History of heart failure history of coagulopathy History of vein thromboembolism History of cancer Kidney disease under dialysis Liver disease Code I82 venous embolism and thrombosis Treatment - Drugs Treatment - Drugs Intervention group: In addition to the standard treatment of venous thromboembolism, from the first day of treatment, they receive rosuvastatin 10 mg dose from Dr. Abidi company, one tablet daily for 3 months Control group: They receive standard treatment for venous thromboembolism (anticoagulants only) Reduce in inflammatory markers. Timepoint: At the moment of start of treatment and 3 months later. Method of measurement: Peripheral blood sample. Reduce of inflammation. Timepoint: 3 months later. Method of measurement: Blood sample. - Approved 2019-07-30 Ethics committee of Shahid Beheshti University of Medical Sciences Tajrish square, Shohada-e-tajrish hospital Tehran Tehran Iran (Islamic Republic of)