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Extended Apixaban for Blood Clot Prevention After Spinal Surgery for Cancer

This study is looking at whether taking a blood-thinning medicine called apixaban (2.5 mg twice daily by mouth) for 30 days after leaving the hospital can prevent dangerous blood clots. These clots, called venous thromboembolism (VTE), deep vein thrombosis (DVT), or pulmonary embolism (PE), can happen after spinal surgery for cancer that has spread. Currently, blood thinners are usually stopped when patients go home. This study wants to see if continuing apixaban for a month after discharge reduces the number of patients who get a VTE within 90 days. You might be able to join if you are 18 or older, had spinal surgery for metastatic disease at UPMC, are going home or to rehab, and can take oral medications. This study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is a single-arm, open-label study, meaning all participants will receive the same treatment and both you and the study team will know what medicine you are taking. It plans to enroll 50 participants.
What's involved
You would take apixaban tablets twice daily for 30 days, starting the day after you leave the hospital. You would also need to be available by telephone for follow-up.
Compensation
Not stated in the trial record.
Follow-up
The study will track whether you develop a symptomatic VTE within 90 days of hospital discharge.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07713875

Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease

Not Yet Recruiting
PHASE4Ages 18+InterventionalPrevention
James Bayley
~50 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Apixaban

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Symptomatic Venous Thromboembolism (VTE)
Measured over Time Frame: Within 90 days of hospital discharge

Conditions

Venous Thromboembolism (VTE)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Spine Metastasis

Explore related trials

Metastatic Malignant Neoplasm in the Spine

Where it's being run

3 sites across 1 states
Pennsylvania3

Who to contact

James Bayley, MD
[email protected]
412-623-7073
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 years or older
Undergone spinal surgery (any approach) for treatment of vertebral metastatic disease at UPMC Presbyterian, Shadyside, or Mercy Hospital
Planned for discharge to home or acute rehabilitation facility (not hospice)
Willing and able to provide written informed consent
Able to take oral medications
Access to a telephone for follow-up calls

Exclusion

Already receiving therapeutic anticoagulation for another indication (e.g., atrial fibrillation, prior VTE, mechanical heart valve)
Planned initiation of therapeutic anticoagulation within the next 30 days for another indication
Known allergy or hypersensitivity to apixaban
History of pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding requiring transfusion or endoscopic intervention within the past 6 months)
Active bleeding at time of planned enrollment
Platelet count less than 50,000/mm³ at time of enrollment
Hemoglobin less than 8 g/dL at time of enrollment
Serum creatinine greater than 2.5 mg/dL
ALT or AST greater than 3 times the upper limit of normal
Total bilirubin greater than 2 times the upper limit of normal
Known severe hepatic impairment (Child-Pugh Class C)
Pregnancy or breastfeeding
Women of childbearing potential unwilling to use adequate contraception during study participation
History of proximal gastrointestinal resection (i.e., gastrectomy and/or proximal small bowel resection) that might alter oral drug absorption
Concurrent use of strong dual inhibitors of CYP3A4 and P-gp or moderate CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem)
Concurrent use of strong dual inducers of CYP3A4 and P-gp (rifampin, carbamazepine, phenytoin, St. John's Wort)
Inability to safely discontinue all antiplatelet medications for the 30-day study drug period, as determined by the treating cardiologist or prescribing physician (aspirin, clopidogrel, ticagrelor)
Inability or unwillingness to discontinue chronic NSAID use during the 30-day study drug period (as-needed use less than 3 days per week is acceptable)
Planned surgery or invasive procedure within the next 30 days
Hospital length of stay 30 days or greater
Prisoner or incarcerated individual
Any other condition that, in the investigator's opinion, would make the subject unsuitable for study participation or unable to comply with study procedures

What this trial measures

  • Incidence of Symptomatic Venous Thromboembolism (VTE)Time Frame: Within 90 days of hospital discharge

    Number of participants who develop symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE), confirmed by imaging (compression ultrasound, CT pulmonary angiogram, or V/Q scan) or adjudicated by clinical criteria per protocol-defined definitions.