Protocol for the impact of medication therapy management on efficacy and safety of postoperative anticoagulation therapy in patients with colorectal cancer: an open-label, prospective and randomized clinical trial.

BACKGROUND

Anticoagulants, classified as high-risk medications, are commonly used and are associated with significant potential harm in postoperative patients. Patients with colorectal cancer (CRC) are among the most susceptible populations. Single-component pharmacist intervention has demonstrated conflicting efficacy in improving anticoagulant safety. Meanwhile, it remains unclear whether comprehensive medication therapy management (MTM), which integrates medication review, personalized education, and long-term follow-up, can effectively reduce adverse drug events (ADEs). This study aims to assess the impact of a comprehensive MTM pathway on anticoagulant-related ADEs in this high-risk population.

METHODS

This study will be a prospective, multicenter, open-label, randomized, parallel-group trial designed to assess the impact of the MTM pathway on anticoagulant efficacy and safety in patients diagnosed with CRC, admitted for elective radical surgery, and developing acute venous thromboembolism (VTE) that requires long-term anticoagulant therapy in comparison with the current clinical standard of care. In total, 327 patients will be enrolled with randomization at a 1:1 ratio into intervention and control groups. Patients in the intervention group will receive MTM interventions at three key time points: during hospitalization, at discharge, and post-discharge. A total of 9 times of MTM services will be provided to patients within 6 months after discharge. The primary outcome is anticoagulant-related clinically important medication errors (CIME), including preventable or ameliorable ADEs and potential ADEs. The secondary outcomes are (I) preventable or ameliorable ADEs; (II) potential ADEs due to discrepancies or non-adherence; and (III) preventable or ameliorable ADEs judged to be serious, life-threatening, or fatal. Intention-to-treat (ITT) analysis will serve as the primary analytical approach.

DISCUSSION: This study will provide evidence on whether the MTM pathway improves the efficacy and safety of anticoagulant therapy in patients with CRC who develop postoperative VTE.

TRIAL REGISTRATION: NCT06998745 (date of registration: 2025-5-10) (Protocol version: 2024-7-16, Version 2.0).