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IRCT20260522069491N1 IRCT 2026-07-15 Tehran University of Medical Sciences Is Rivaroxaban safe and how does it work for Preventing Blood Clots After Colon Cancer Surgery, Compared to Enoxaparin? Evaluation of the Efficacy and Safety of Rivaroxaban Versus Enoxaprin (Low-Molecular-Weight Heparin) As Post-surgical Thromboprohylaxis of Colorectal Cancer: A Randomized Clinical Trial 2026-07-01 anticipated 110 Recruiting https://irct.ir/trial/91320 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Sequentially numbered, opaque, sealed envelopes will be used. These envelopes will be prepared by an individual with no executive or clinical role in the study, and the codes on them will correspond to the master randomization list. Only after final confirmation of eligibility criteria and obtainment of written informed consent will the envelope corresponding to the patient be opened in numerical sequence. This process completely prevents selection bias at the stage of study enrollment. The study will be conducted in a double-blind manner. Given the difference in the physical nature of the medications (tablet versus prefilled syringe), all medications and injection supplies will be placed in kit-like packaging (Study Kits) with completely identical appearance, weight, and dimensions. Each medication kit will bear only a unique identification code. Patients, nursing staff, treating physicians, and even outcome assessors (Doppler ultrasound specialists) will remain blinded to the contents of the kits until the completion of the data analysis phase. The master code list will be held exclusively by the Principal Investigator in an encrypted file. Unblinding will be performed only in medical emergencies where knowledge of the drug type is essential to save the patient's life, in accordance with the approved protocol. 3 Condition 1: Ascending colon cancer. Condition 2: transverse colon cancer. Condition 3: descending colon cancer. Condition 4: sigmoid colon cancer. Condition 5: rectum cancer. Condition 6: deep vein thrombosis. Condition 7: pulmonary embolism. Intervention 1: Intervention group: Fifty-five patients in this group will receive one 10-mg tablet of rivaroxaban (Actoverco) once daily for 28 days as postoperative thromboprophylaxis following colorectal cancer surgery at Imam Khomeini Hospital, Tehran. During hospitalization, rivaroxaban will be prescribed through the hospital ward's medication order system. Upon discharge, patients will be instructed on the proper administration of the medication. In addition, each patient will be provided with a sufficient number of rivaroxaban tablets to complete the 28-day treatment course. Intervention 2: Control group: Fifty-five patients in this group will receive one 40-mg subcutaneous injection of enoxaparin sodium (Exir Pharmaceutical Company) once daily for 28 days as postoperative thromboprophylaxis following colorectal cancer surgery at Imam Khomeini Hospital, Tehran. During hospitalization, the medication will be prescribed through the hospital ward's medication order system. Upon discharge, patients will receive instructions on the proper administration of the medication. In addition, each patient will be provided with a sufficient supply of enoxaparin sodium to complete the 28-day treatment course. Yes - There is a plan to make this available What will be shared: Patient data, including age, sex, body mass index (BMI), cancer stage, type of surgery, and history of previous venous thromboembolism (VTE), will be recorded without including any patient identifiers in the final report. The study protocol will document the methodology of randomization, the study period, the patient follow-up procedures, and the patient selection criteria. A blank copy of the informed consent form will be included in the study documentation, and the completed informed consent forms of all participants will be securely retained. Upon completion of the study, statistical analyses will be performed on the collected variables, and the results will be presented in the final report When: Access to the study data will begin three months after publication of the study results. To whom: Data access will be granted only to researchers affiliated with accredited academic and scientific institutions. Conditions: The data may be used for conducting related research, including literature reviews, systematic reviews, and meta-analyses. Where to obtain: via email to: aysa.rezaei80@gmail.com or jamil.nadimi@gmail.com How to obtain: To obtain access to the data, applicants will be required to provide their full name, academic affiliation and position, and a summary of their research background. They must also submit a description of the purpose of the data request, the proposed research plan, and the anticipated timeline and method for dissemination of the study findings. Comments:
public Aysa Rezaei
School of Medicine, Tehran University of Medical Sciences, Poursina Street, Qods Street, Enghelab Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1461884513 +98 21 8896 1697 aysa.rezaei80@gmail.com Tehran University of Medical Sciences scientific Mohsen Ahmadi Tafti
Tehran, end of Keshavarz Boulevard, Imam Khomeini Hospital Complex, Mahdi Clinic, Colorectal surgery department
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 5462 Imamhospital@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Candidate for colorectal cancer surgery Pathological confirmation of colorectal adenocarcinoma Patient consent Hospitalization for 6 to 7 days following surgery Adequate renal function (creatinine clearance ≥30 mL/min) Adequate hepatic function (ALT/AST <3 times the upper limit of normal) 18 years no limit Both Active bleeding High risk of bleeding with anticoagulant use Concurrent use of anticoagulants (particularly warfarin and apixaban) Use of strong CYP3A4 inducers (e.g., rifampin, rifabutin, carbamazepine, phenytoin, phenobarbital, or St. John's Wort [Hypericum perforatum]) Use of dabigatran or edoxaban Use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, posaconazole, erythromycin, indinavir, saquinavir, Verapamil, diltiazem, amiodarone, quinidine) Use of mifepristone or urokinase History of heparin-induced thrombocytopenia Inadequate renal function (creatinine clearance <30 mL/min) Inadequate hepatic function (Child-Pugh Class C) Pregnancy or lactation Platelet count <50,000/μL Major bleeding within the past 30 days Emergency surgery Metastatic disease with a life expectancy of less than three months History of thromboembolism within the past 3 months C18.2 C18.4 C18.6 C18.7 C20 I82.4 I26 Malignant neoplasm of ascending colon Malignant neoplasm of transverse colon Malignant neoplasm of descending colon Malignant neoplasm of sigmoid colon Malignant neoplasm of rectum Acute embolism and thrombosis of deep veins of lower extremity Pulmonary embolism Treatment - Drugs Treatment - Drugs Intervention group: Fifty-five patients in this group will receive one 10-mg tablet of rivaroxaban (Actoverco) once daily for 28 days as postoperative thromboprophylaxis following colorectal cancer surgery at Imam Khomeini Hospital, Tehran. During hospitalization, rivaroxaban will be prescribed through the hospital ward's medication order system. Upon discharge, patients will be instructed on the proper administration of the medication. In addition, each patient will be provided with a sufficient number of rivaroxaban tablets to complete the 28-day treatment course. Control group: Fifty-five patients in this group will receive one 40-mg subcutaneous injection of enoxaparin sodium (Exir Pharmaceutical Company) once daily for 28 days as postoperative thromboprophylaxis following colorectal cancer surgery at Imam Khomeini Hospital, Tehran. During hospitalization, the medication will be prescribed through the hospital ward's medication order system. Upon discharge, patients will receive instructions on the proper administration of the medication. In addition, each patient will be provided with a sufficient supply of enoxaparin sodium to complete the 28-day treatment course. Symptomatic venous thromboembolism (VTE). Timepoint: Development of symptoms including severe dyspnea or unilateral lower extremity swelling up to 90 days after surgery. Method of measurement: Clinical and imaging diagnosis. A symptomatic venous thromboembolism (VTE). Timepoint: Final day of hospitalization, day 30, and day 90 after surgery. Method of measurement: Venous Doppler ultrasound. Death resulting from venous thromboembolism (VTE). Timepoint: Death within 90 days after surgery due to venous thromboembolism (VTE). Method of measurement: Medical record, death report. Major bleeding. Timepoint: Within 90 days after surgery. Method of measurement: Clinical report, medical record. Clinically relevant non-major bleeding. Timepoint: Within 90 days after surgery. Method of measurement: Clinical report, medical record. Tehran University of Medical Sciences Approved 2026-05-19 Research Ethics Committee, Vice Chancellor for Research and Technology, Tehran University of Medical Keshavarz Boulevard, corner of Qods Street, Central Administration Building, Tehran University of Medical Sciences, 6th Floor, Rooms 604–605 Tehran Tehran Iran (Islamic Republic of)