SUNY Upstate
Syracuse, New York, 13210, United States
Location status: Recruiting
NCT Number: NCT07189897
The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines.
The main questions it aims to answer are:
Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine?
Researchers will compare 2 groups:
One group will take apixaban (a pill taken twice a day) for 10 days after surgery.
The other group will take enoxaparin (a shot given once a day) for 10 days after surgery.
Participants will:
Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks
How long will participation last? About 4 months from surgery through the last follow-up visit.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Phase 4
Syracuse, New York, 13210, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must:
Eligible diagnoses include (not limited to):
Exclusion criteria
Participants cannot:
For DVT prophylaxis
For DVT prophylaxis
Time frame: From study start until target enrollment is reached (up to 24 months).
Enrollment rate will be calculated as the number of participants enrolled, divided by the number of eligible participants, multiplied by 100%.
Time frame: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Mean Anti-Clot Treatment Scale (ACTS) score. The ACTS comprises two primary subscales: ACTS Burdens and ACTS Benefits. The ACTS scores range from 12 to 60, but are often reverse-coded so that higher values indicate greater satisfaction. The ACTS Benefits scores range from 3 to 15, where higher scores reflect higher satisfaction.
Time frame: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Mean Treatment Satisfaction Questionnaire for Medication (TSQM) - 1.4 score. TSQM 1.4 has four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Each domain is scored separately on a scale from 0 to 100, where higher scores indicate greater satisfaction.
Contact information is provided by the study sponsor or research team.
Kiranya Arnold
Other
An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery
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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