Venous Thromboembolism (VTE)Phase 4NCT07713875
Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
A Phase 4 study testing Apixaban in people with Venous Thromboembolism (VTE) and Deep Vein Thrombosis (DVT), run by James Bayley at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
UPMC Presbyterian Hospital
Pittburgh, Pennsylvania, 15213
James Bayley, MD, 412-623-7073, bayleyjc2@upmc.edu
UPMC Shadyside Hospital
Pittburgh, Pennsylvania, 15232
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
James Bayley, MD, 412-623-7073, bayleyjc2@upmc.edu
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Spine Metastasis
- Being tested
- Apixaban
- Keywords
- Apixaban, Eliquis, Extended thromboprophylaxis, Postoperative anticoagulation, Spine surgery, Cancer surgery, VTE prophylaxis, Direct oral anticoagulant, DOAC, Factor Xa inhibitor, Metastatic bone disease
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Prophylactic Anticoagulation | Experimental | 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. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Within 90 days of hospital discharge
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: Day 31 post-discharge
Incidence of Spinal Epidural Hematoma Requiring Intervention
Number of participants who develop spinal epidural hematoma requiring surgical intervention.
Measured: Within 90 days of hospital discharge
Hospital Readmission Rate
Number of participants readmitted to the hospital for any reason.
Measured: Within 90 days of hospital discharge
Emergency Department Visits
Number of participants with at least one emergency department visit.
Measured: Within 90 days of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, prospective, open-label interventional study. All enrolled participants receive apixaban 2.5 mg orally twice daily for 30 days following hospital discharge after spinal surgery for metastatic disease. Outcomes are compared to a historical control cohort of 68 patients who underwent the same type of surgery but did not receive extended prophylactic anticoagulation after discharge. The historical cohort is not a randomized arm; data were collected retrospectively via medical record review.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James Bayley
- Sponsor type
- University, hospital or other
- Collaborators
- The Greg Beckwith Foundation
- Responsible party
- Sponsor-investigator, James Bayley, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713875
- Sponsor's protocol ID
- STUDY25120085
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mahe I, Carrier M, Mayeur D, Chidiac J, Vicaut E, Falvo N, Sanchez O, Grange C, Monreal M, Lopez-Nunez JJ, Otero-Candelera R, Le Gal G, Yeo E, Righini M, Robert-Ebadi H, Huisman MV, Klok FA, Westerweel P, Agnelli G, Becattini C, Bamias A, Syrigos K, Szmit S, Torbicki A, Verhamme P, Maraveyas A, Cohen AT, Ay C, Chapelle C, Meyer G, Couturaud F, Mismetti P, Girard P, Bertoletti L, Laporte S; API-CAT Investigators. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. 2025 Apr 10;392(14):1363-1373. doi: 10.1056/NEJMoa2416112. Epub 2025 Mar 29.
PubMed 40162636Carrier M, Abou-Nassar K, Mallick R, Tagalakis V, Shivakumar S, Schattner A, Kuruvilla P, Hill D, Spadafora S, Marquis K, Trinkaus M, Tomiak A, Lee AYY, Gross PL, Lazo-Langner A, El-Maraghi R, Goss G, Le Gal G, Stewart D, Ramsay T, Rodger M, Witham D, Wells PS; AVERT Investigators. Apixaban to Prevent Venous Thromboembolism in Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):711-719. doi: 10.1056/NEJMoa1814468. Epub 2018 Dec 4.
PubMed 30511879Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009 Aug 6;361(6):594-604. doi: 10.1056/NEJMoa0810773.
PubMed 19657123Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.
PubMed 20206776Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.
PubMed 21175312Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schuunemann HJ; American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):7S-47S. doi: 10.1378/chest.1412S3. No abstract available.
PubMed 22315257Sweetland S, Green J, Liu B, Berrington de Gonzalez A, Canonico M, Reeves G, Beral V; Million Women Study collaborators. Duration and magnitude of the postoperative risk of venous thromboembolism in middle aged women: prospective cohort study. BMJ. 2009 Dec 3;339:b4583. doi: 10.1136/bmj.b4583.
PubMed 19959589Bergqvist D, Agnelli G, Cohen AT, Eldor A, Nilsson PE, Le Moigne-Amrani A, Dietrich-Neto F; ENOXACAN II Investigators. Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer. N Engl J Med. 2002 Mar 28;346(13):975-80. doi: 10.1056/NEJMoa012385.
PubMed 11919306Zhang L, Cao H, Chen Y, Jiao G. Risk factors for venous thromboembolism following spinal surgery: A meta-analysis. Medicine (Baltimore). 2020 Jul 17;99(29):e20954. doi: 10.1097/MD.0000000000020954.
PubMed 32702835De la Garza Ramos R, Longo M, Gelfand Y, Echt M, Kinon MD, Yassari R. Timing of Prophylactic Anticoagulation and Its Effect on Thromboembolic Events After Surgery for Metastatic Tumors of the Spine. Spine (Phila Pa 1976). 2019 Jun 1;44(11):E650-E655. doi: 10.1097/BRS.0000000000002944.
PubMed 30475345Groot OQ, Ogink PT, Paulino Pereira NR, Ferrone ML, Harris MB, Lozano-Calderon SA, Schoenfeld AJ, Schwab JH. High Risk of Symptomatic Venous Thromboembolism After Surgery for Spine Metastatic Bone Lesions: A Retrospective Study. Clin Orthop Relat Res. 2019 Jul;477(7):1674-1686. doi: 10.1097/CORR.0000000000000733.
PubMed 31135550Key NS, Khorana AA, Kuderer NM, Bohlke K, Lee AYY, Arcelus JI, Wong SL, Balaban EP, Flowers CR, Francis CW, Gates LE, Kakkar AK, Levine MN, Liebman HA, Tempero MA, Lyman GH, Falanga A. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2020 Feb 10;38(5):496-520. doi: 10.1200/JCO.19.01461. Epub 2019 Aug 5.
PubMed 31381464Agnelli G, Bolis G, Capussotti L, Scarpa RM, Tonelli F, Bonizzoni E, Moia M, Parazzini F, Rossi R, Sonaglia F, Valarani B, Bianchini C, Gussoni G. A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: the @RISTOS project. Ann Surg. 2006 Jan;243(1):89-95. doi: 10.1097/01.sla.0000193959.44677.48.
PubMed 16371741
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
- ClinicalTrials.gov ID
- NCT07713875
- Acronym / sponsor ID
- STUDY25120085
- Conditions
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Spine Metastasis
- Keywords
- Apixaban, Eliquis, Extended thromboprophylaxis, Postoperative anticoagulation, Spine surgery, Cancer surgery, VTE prophylaxis, Direct oral anticoagulant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- James BayleyUniversity, hospital or other
- Collaborators
- The Greg Beckwith Foundation
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective, open-label interventional study. All enrolled participants receive apixaban 2.5 mg orally twice daily for 30 days following hospital discharge after spinal surgery for metastatic disease. Outcomes are compared to a historical control cohort of 68 patients who underwent the same type of surgery but did not receive extended prophylactic anticoagulation after discharge. The historical cohort is not a randomized arm; data were collected retrospectively via medical record review.
| Arm | Type | Receives |
|---|---|---|
| Extended Prophylactic Anticoagulation | Experimental | Drug: ApixabanApixaban 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: EliquisApixaban 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. | Drug | Extended Prophylactic Anticoagulation |
Primary outcome
Incidence of Symptomatic Venous Thromboembolism (VTE)
Time frame: 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.
6 secondary outcomes
Incidence of Major Bleeding Events
Time frame: Within 90 days of hospital discharge
Incidence of Clinically Relevant Non-Major Bleeding Events
Time frame: Within 90 days of hospital discharge
Medication Adherence
Time frame: Day 31 post-discharge
Incidence of Spinal Epidural Hematoma Requiring Intervention
Time frame: Within 90 days of hospital discharge
Hospital Readmission Rate
Time frame: Within 90 days of hospital discharge
Emergency Department Visits
Time frame: Within 90 days of hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 40162636Mahe I, Carrier M, Mayeur D, Chidiac J, Vicaut E, Falvo N, Sanchez O, Grange C, Monreal M, Lopez-Nunez JJ, Otero-Candelera R, Le Gal G, Yeo E, Righini M, Robert-Ebadi H, Huisman MV, Klok FA, Westerweel P, Agnelli G, Becattini C, Bamias A, Syrigos K, Szmit S, Torbicki A, Verhamme P, Maraveyas A, Cohen AT, Ay C, Chapelle C, Meyer G, Couturaud F, Mismetti P, Girard P, Bertoletti L, Laporte S; API-CAT Investigators. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. 2025 Apr 10;392(14):1363-1373. doi: 10.1056/NEJMoa2416112. Epub 2025 Mar 29.
- Background: PubMed 30511879Carrier M, Abou-Nassar K, Mallick R, Tagalakis V, Shivakumar S, Schattner A, Kuruvilla P, Hill D, Spadafora S, Marquis K, Trinkaus M, Tomiak A, Lee AYY, Gross PL, Lazo-Langner A, El-Maraghi R, Goss G, Le Gal G, Stewart D, Ramsay T, Rodger M, Witham D, Wells PS; AVERT Investigators. Apixaban to Prevent Venous Thromboembolism in Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):711-719. doi: 10.1056/NEJMoa1814468. Epub 2018 Dec 4.
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- Background: PubMed 21175312Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.
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- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban in people with Venous Thromboembolism (VTE) and Deep Vein Thrombosis (DVT), run by James Bayley at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Bayley, MD (412-623-7073, bayleyjc2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Symptomatic Venous Thromboembolism (VTE) (time frame: Time Frame: Within 90 days of hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713875, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.