A Phase 4 interventional study of Apixaban in Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), sponsored by James Bayley. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by James Bayley · Phase 4, Interventional, and Prevention
People who have surgery on their spine to treat cancer that has spread (metastatic disease) have a high chance of developing dangerous blood clots in the legs or lungs. These blood clots are called deep vein thrombosis (DVT) or pulmonary embolism (PE). In a review of patients at UPMC who had this type of surgery, about 15 out of 100 developed a blood clot within 90 days of leaving the hospital.
Right now, patients receive blood-thinning medicine only while they are in the hospital after surgery. Once they go home, the medicine is stopped. There are no guidelines telling doctors whether blood-thinning medicine should continue after patients go home from spine surgery for cancer. However, for other types of major cancer surgery, studies have shown that continuing blood-thinning medicine for about 4 weeks after surgery can help prevent blood clots.
This study will test whether taking a blood-thinning medicine called apixaban (brand name Eliquis) by mouth for 30 days after leaving the hospital can help prevent blood clots in patients who have had spine surgery for cancer that has spread. The dose used in this study (2.5 mg twice a day) is the same dose approved by the U.S. Food and Drug Administration (FDA) for preventing blood clots after hip and knee replacement surgery.
About 50 adults at UPMC will take part. Participants will take apixaban for 30 days starting the day after hospital discharge. The study team will call participants by phone three times - about 2 days, 31 days, and 91 days after discharge - to check on their health, ask about any bleeding or blood clot symptoms, and assess medication use. No extra clinic visits are required. Results will be compared to a group of 68 patients who had the same type of surgery in the past but did not take apixaban after leaving the hospital.
The main goal is to find out if apixaban reduces the rate of blood clots within 90 days of hospital discharge. The study will also track bleeding events and other side effects to determine if this approach is safe. The study hypothesis is that extended blood-thinning medicine after surgery will reduce blood clots compared to the current approach of stopping this medicine at hospital discharge.
Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in patients undergoing surgery for metastatic spinal disease. Published series report 90-day symptomatic VTE rates of 11-15% in this population, with a substantial proportion of events occurring after hospital discharge when standard inpatient prophylaxis has ceased. Current guidelines from ASCO and ACCP recommend extended pharmacologic VTE prophylaxis (4 weeks postoperatively) following major abdominal and pelvic cancer surgery, supported by evidence from the ENOXACAN II trial and others. However, no guidelines or prospective data exist regarding extended VTE prophylaxis after spinal surgery for metastatic disease, despite comparable or greater VTE risk.
A retrospective analysis of 68 consecutive patients who underwent surgery for spinal metastatic disease at UPMC between January 2022 and December 2024 identified a 90-day symptomatic VTE rate of 14.7% (10/68) and a 90-day all-cause mortality rate of 16% (11/68), confirming the high burden of this complication in the local population.
This is a single-arm, prospective, open-label interventional pilot study evaluating extended prophylactic anticoagulation with apixaban 2.5 mg orally twice daily for 30 days following hospital discharge. The study population consists of adults (≥18 years) who have undergone spinal surgery for vertebral metastatic disease at UPMC Presbyterian, Shadyside, or Mercy hospitals. Key exclusion criteria include active therapeutic anticoagulation, active bleeding, severe hepatic or renal impairment, concurrent use of strong CYP3A4/P-gp inhibitors or inducers, and inability to discontinue antiplatelet agents or chronic NSAIDs.
Apixaban 2.5 mg BID is FDA-approved for VTE prophylaxis following hip replacement (35 days) and knee replacement (12 days). The proposed dose and route are identical to the approved prophylactic regimen. In the ADVANCE-3 trial, apixaban 2.5 mg BID demonstrated superior efficacy to enoxaparin with major bleeding rates of 0.8% vs 0.7%. The AVERT trial demonstrated a 59% reduction in VTE with apixaban 2.5 mg BID in ambulatory cancer patients at intermediate-to-high VTE risk.
The primary endpoint is the incidence of symptomatic VTE (DVT and/or PE) within 90 days of hospital discharge. Key secondary endpoints include major bleeding events (ISTH criteria), clinically relevant non-major bleeding events (ISTH criteria), and all-cause mortality at 90 days. Additional secondary endpoints include medication adherence (pill count at Day 31), spinal epidural hematoma requiring intervention, hospital readmission rates, and emergency department visits within 90 days.
Follow-up consists of telephone calls at approximately Day 2, Day 31, and Day 91 post-discharge, supplemented by periodic medical record review. No additional clinic visits are required.
Outcomes in the prospective cohort (target N=50) will be compared to the historical control cohort (N=68). The primary statistical analysis uses a Bayesian comparison of binomial proportions with a uniform (non-informative) prior distribution. Based on Bayesian power calculations, with 50 enrolled subjects and accounting for an expected 16% attrition from mortality and loss to follow-up (yielding approximately 40-42 evaluable subjects), a 46% reduction in VTE incidence would provide an 85.2% posterior probability of benefit, and a 59% reduction would provide a 92.3% posterior probability of benefit.
Stopping rules are pre-specified: enrollment will be paused if ≥2 major bleeding events or ≥4 clinically relevant non-major bleeding events occur. Any single fatal bleeding event or spinal epidural hematoma will trigger immediate safety review. An independent safety monitor provides oversight.
This study is conducted under an IND exemption per 21 CFR 312.2(b)(1). Results will inform the design and sample size of a future multicenter randomized controlled trial.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 50 is below the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →This is the only study on the registry with James Bayley as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apixaban 2.5 mg orally twice daily for 30 days beginning the day after hospital discharge following spinal surgery for metastatic disease. Participants also receive standard inpatient VTE prophylaxis (subcutaneous heparin or enoxaparin) from postoperative day 1 through discharge, per routine clinical care.
Drug: Apixaban
Apixaban 2.5 mg tablet taken orally twice daily (morning and evening) for 30 days, starting the day after hospital discharge. This is the FDA-approved prophylactic dose for VTE prevention following hip and knee replacement surgery.
Also known as: Eliquis
Incidence of Symptomatic Venous Thromboembolism (VTE)
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.
Time frame: Time Frame: Within 90 days of hospital discharge
Incidence of Major Bleeding Events
Number of participants experiencing major bleeding as defined by International Society on Thrombosis and Haemostasis (ISTH) criteria: fatal bleeding, bleeding in a critical organ, bleeding causing hemoglobin drop ≥2 g/dL, or bleeding requiring transfusion of ≥2 units of packed red blood cells.
Time frame: Within 90 days of hospital discharge
Incidence of Clinically Relevant Non-Major Bleeding Events
Number of participants experiencing clinically relevant non-major (CRNM) bleeding as defined by ISTH criteria: overt bleeding not meeting major bleeding criteria but requiring medical intervention, unscheduled physician contact, temporary cessation of study drug, or causing impairment of daily activities.
Time frame: Within 90 days of hospital discharge
Medication Adherence
Proportion of participants achieving ≥80% adherence based on self-reported pill count at Day 31. Adherence calculated as (60 minus remaining pills) divided by 60.
Time frame: Day 31 post-discharge
Incidence of Spinal Epidural Hematoma Requiring Intervention
Number of participants who develop spinal epidural hematoma requiring surgical intervention.
Time frame: Within 90 days of hospital discharge
Hospital Readmission Rate
Number of participants readmitted to the hospital for any reason.
Time frame: Within 90 days of hospital discharge
Emergency Department Visits
Number of participants with at least one emergency department visit.
Time frame: Within 90 days of hospital discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared. De-identified aggregate data may be made available to qualified researchers upon reasonable request to the Principal Investigator after publication of study results.
Start is estimated for Aug 2026; primary completion for Nov 2027, 15 months later.
Of 34 phase 4 interventional studies under Venous Thromboembolism, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 88. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apixaban