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NCT Number: NCT06998745

The Impact of MTM Model on the Efficacy and Safety of Anticoagulant Therapy in Postoperative Colorectal Cancer Patients

Anticoagulants are classified as high-risk medications, with their main adverse drug events (ADEs) being recurrent venous thromboembolism (VTE) and bleeding events.Postoperative colorectal cancer (CRC) patients exhibit a high probability of recurrent VTE and bleeding during anticoagulation therapy.The Medication Therapy Management (MTM) model will contribute to reducing ADEs associated with anticoagulants in CRC patients.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 5106555, China

Location status: Recruiting

Location contact

xiaoyan li, Study Principal Invertigator

CONTACT

[email protected]

13609066172

About this study

Anticoagulants are classified as high-risk medications, with their main adverse drug events (ADEs) being recurrent venous thromboembolism (VTE) and bleeding events.Postoperative colorectal cancer (CRC) patients exhibit a high probability of recurrent VTE and bleeding during anticoagulation therapy. In clinical practice, a considerable proportion of patients have experienced inappropriate prescribing of anticoagulants. Following a bleeding event, the decision on whether and when to initiate anticoagulation therapy requires individualized assessment by physicians and pharmacists based on each patient's specific condition. Moreover, over a quarter of patients prematurely discontinue anticoagulation therapy, which substantially increases their risk of VTE recurrence.Effective management of the use of anticoagulants holds significant importance. Pharmacist-led anticoagulation management can significantly improve the appropriateness of anticoagulant therapy and reduce total bleeding risk. However, the efficacy of various intervention approaches, such as medication reconciliation and medication monitoring, as well as the timing of intervention, has not been conclusively established. This study integrates multifaceted pharmacist interventions within the Medication Therapy Management (MTM) model, intervening at patient admission, during hospitalization, and post-discharge, to evaluate the impact of the MTM model on the efficacy and safety of anticoagulation therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment.
  • CRC patients with VTE treated with an anticoagulant for at least 3 moths.

Exclusion criteria

1.Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.

Treatment and study plan

Medication Therapy Management (MTM) model

Behavioral

MTM model comprising five core elements: Medication Therapy Review (MTR), Personal Medication Record (PMR), Medication-Related Action Plan (MAP), interventions & referrals, and documentation & follow-up

Primary outcomes

  1. Clinically Important Medication Errors (CIME) related to anticoagulant therapy

    Time frame: From the time of the patient's admission to 6 months after discharge.

    The primary outcome is CIME related to anticoagulation therapy, which constitute a composite endpoint comprising preventable or ameliorable adverse drug events (ADEs) and potential ADEs arising from medication discrepancies or non-adherence. The primary anticoagulant-related ADEs that this trial plans to observe encompass two categories: (i) ADEs associated with the therapeutic effects of anticoagulant, including all-cause mortality, suspected recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE), confirmed symptomatic or incidental DVT, and confirmed symptomatic or incidental PE; (ii) ADEs related to the major adverse drug reactions, such as major bleeding, clinical related non-major bleeding, and minor bleeding.

Secondary outcomes

  1. Preventable adverse drug events (ADEs)

    Time frame: From the time of the patient's admission to 6 months after discharge.

    Preventable ADEs are drug-related injuries associated with medication errors

  2. Ameliorable adverse drug events (ADEs)

    Time frame: From the time of the patient's admission to 6 months after discharge.

    Although some ADEs may not be entirely preventable, their duration or severity can be reduced, and are thus termed ameliorable ADEs.

  3. Potential adverse drug events (ADEs)

    Time frame: From the time of the patient's admission to 6 months after discharge.

    There are other medication-related issues that may arise after discharge, known as potential ADEs, although these situations have not yet caused any harm to patients, if left untreated, they could lead to future harm.

Study contacts

Contact information is provided by the study sponsor or research team.

xiaoyan li

CONTACT

[email protected]

13609066172

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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