EHR Alerts for Blood Clot Prevention

(eVTE Trial)

Overseen By Carlos Barbagelata, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scott C. Woller, MD

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Low creatinine clearance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

152000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pop-up alert system for doctors to help determine if patients leaving the hospital should receive the blood thinner rivaroxaban (also known as Xarelto or BAY 59-7939). The goal is to prevent blood clots in patients with high clot risk but low bleeding risk. The study will compare hospitals using the alert with those not using it to assess whether it increases rivaroxaban prescriptions and reduces blood clots. Individuals who have been hospitalized and have a high risk of blood clots but a low risk of bleeding might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to innovative healthcare solutions that could improve patient outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are already on certain blood thinners like apixaban or warfarin, you would not be eligible to participate.

What prior data suggests that this alert system is safe for patients?

Research has shown that rivaroxaban is generally well-tolerated by patients needing to prevent blood clots. Studies have found that rivaroxaban effectively reduces blood clots after surgeries like hip replacements. It matches the effectiveness of enoxaparin, another blood thinner, but offers more convenience with once-daily dosing.

The main safety concern is the risk of major bleeding. However, rivaroxaban shares a similar safety profile with enoxaparin, indicating that the risk of serious bleeding is comparable. This suggests it is a safe option for those needing to prevent clots and who have a low risk of bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using electronic health record (EHR) alerts to improve the prevention of blood clots, specifically venous thromboembolism (VTE), at hospital discharge. Unlike current treatments that rely on physician judgment or standard protocols, this approach proactively notifies healthcare providers to consider prescribing rivaroxaban for patients at high risk for VTE but with a low risk of bleeding. This method aims to enhance decision-making right at the point of care, potentially reducing the incidence of VTE more effectively than existing practices.

What evidence suggests that this pop-up alert is effective for reducing blood clots?

Research has shown that rivaroxaban helps prevent blood clots, such as deep vein thrombosis (DVT) and pulmonary embolism (PE). In past studies, rivaroxaban performed as well as standard treatments for DVT and maintained a similar safety level. Another study found it reduced blood clots after hip replacement surgery. In this trial, one group of at-risk patients will receive alerts to consider prescribing rivaroxaban to reduce venous thromboembolism. These findings suggest that rivaroxaban could help prevent blood clots in at-risk patients without significantly increasing the risk of bleeding. ^{1 3 5 6 7}

Who Is on the Research Team?

Scott C. Woller, MD

Principal Investigator

Intermountain Health

Are You a Good Fit for This Trial?

This trial is for patients recently discharged from the hospital who are at high risk of developing blood clots, such as deep vein thrombosis or pulmonary embolism, but have a low risk of bleeding. Specific eligibility criteria details were not provided.

Inclusion Criteria

I have a signed order to be discharged from the hospital.

I am at high risk for blood clots and low risk for bleeding.

Discharging clinician must be in one of the following iCentra electronic health record (Cerner, Kansas City, MO) positions: Physician, nurse practitioner, or physician assistant hospitalist, Physician internal medicine, Physician family medicine

Exclusion Criteria

I am not currently prescribed any of the listed anticoagulant medications.

My kidneys are functioning well enough for treatment.

Pregnant during encounter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (in-person)

Baseline

Patients are monitored without the alert to assess baseline prescription rates of rivaroxaban

1 month

Intervention

Implementation of the pop-up alert to guide extended duration thromboprophylaxis prescription

1 month

Follow-up

Participants are monitored for safety and effectiveness after intervention

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism

Trial Overview The study tests if an EHR alert about prescribing rivaroxaban to reduce blood clot risks affects clinician behavior and patient outcomes. Hospitals will activate this alert in monthly blocks to compare results.

How Is the Trial Designed?

Group I: At-risk patients for which an alert is sent during the intervention phase Experimental Treatment 1 Intervention

Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), thereby meeting criteria for alerting during the intervention phase

Group II: At-risk patients during the baseline phase Active Control 1 Intervention

Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), and who meet criteria for alerting, but for whom no alert is sent during the baseline phase

Who Is Running the Clinical Trial?

Scott C. Woller, MD

Lead Sponsor

Trials

2

Recruited

152,000+

Janssen Pharmaceuticals

Industry Sponsor

Trials

87

Recruited

208,000+

Joaquin Duato

Janssen Pharmaceuticals

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Pharmaceuticals

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study involving 17,701 patients across 252 centers, rivaroxaban was found to significantly reduce the incidence of symptomatic thromboembolic events compared to standard thromboprophylaxis, demonstrating its superior efficacy in preventing blood clots after hip or knee surgery.

The safety profile of rivaroxaban was similar to that of standard care, with comparable rates of major bleeding events, confirming its favorable benefit-risk profile in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Turpie, AG., Haas, S., Kreutz, R., et al.[2015]

Rivaroxaban is a direct factor Xa inhibitor that offers a simplified alternative to traditional vitamin K antagonists like warfarin, allowing for once-daily dosing without the need for frequent monitoring or dose adjustments.

In phase-II and phase-III trials involving over 24,000 patients, rivaroxaban has demonstrated safety and efficacy for preventing and treating venous thromboembolism, and is also being studied for other conditions like pulmonary embolism and stroke prevention in atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban. Mousa, SA.[2015]

In a study of 899 patients with non-valvular atrial fibrillation in the Netherlands, rivaroxaban showed low rates of major bleeding (2.4 per 100 patient-years) and all-cause mortality (1.0 per 100 patient-years) over a one-year follow-up, indicating its safety in routine clinical practice.

The study also found that 13.8% of patients temporarily interrupted their rivaroxaban treatment, and 11.8% switched to another anticoagulant, highlighting the importance of monitoring dosing regimens and patient adherence to optimize the use of NOACs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life use of Rivaroxaban in the Netherlands: data from the Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation (XANTUS) registry. Pisters, R., van Vugt, SPG., Brouwer, MA., et al.[2022]

In a study involving 13,609 patients using rivaroxaban and 32,244 using warfarin for venous thromboembolism (VTE), rivaroxaban was found to reduce the risk of recurrent VTE by 19% and major bleeding by 21% compared to warfarin.

Rivaroxaban also significantly lowered the risk of intracranial hemorrhage (ICH) and gastrointestinal bleeding (GIB), indicating it may be a safer option for patients in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism. Coleman, CI., Bunz, TJ., Turpie, AGG.[2018]

In a study involving 5142 patients, rivaroxaban demonstrated a lower incidence of major bleeding (0.8%) compared to standard anticoagulation therapy (2.1%), suggesting it may be a safer option for treating deep-vein thrombosis.

Rivaroxaban also showed comparable effectiveness in preventing recurrent venous thromboembolism (1.4% vs. 2.3% for standard therapy), indicating it is an effective alternative in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Ageno, W., Mantovani, LG., Haas, S., et al.[2022]

Rivaroxaban (Xarelto®) is more effective than enoxaparin in preventing venous thromboembolism (VTE) after total hip or knee replacement surgery, with a significantly lower incidence of total VTE (1.1% vs. 3.7%) in a large clinical trial involving postoperative patients.

Rivaroxaban achieves this greater efficacy without a significant increase in major bleeding events compared to enoxaparin, making it a safer option for patients undergoing these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban: a review of its use for the prophylaxis of venous thromboembolism after total hip or knee replacement surgery. Duggan, ST.[2015]

Rivaroxaban is an effective oral medication that inhibits Factor Xa, showing significant efficacy in preventing and treating thromboembolic disorders, including venous thromboembolism after major orthopedic surgery.

In phase III studies, rivaroxaban was found to be more effective than enoxaparin for preventing blood clots after knee surgery, with a similar low risk of bleeding, making it a promising alternative to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. Perzborn, E., Kubitza, D., Misselwitz, F.[2015]

Rivaroxaban has been shown to be more effective than enoxaparin in preventing venous thromboembolism (VTE) in orthopedic patients, based on a comprehensive study involving 12,729 patients in the RECORD program.

The safety profile of rivaroxaban is excellent, with no significant increase in major bleeding events compared to enoxaparin, making it a promising option for VTE prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of rivaroxaban in the prevention of venous thromboembolism following hip and knee replacement surgery: a review of clinical trial data. Kwong, LM.[2022]

Rivaroxaban, a direct Factor Xa inhibitor, has been evaluated in over 24,000 patients across Phase II and III trials for its safety and efficacy in preventing and treating venous thromboembolism, showing promise as an alternative to traditional vitamin K antagonists like warfarin.

The drug is also being studied for various conditions, including pulmonary embolism and stroke prevention in patients with non-valvular atrial fibrillation, indicating its potential broad application in thrombosis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban, an oral direct factor Xa inhibitor. Piccini, JP., Patel, MR., Mahaffey, KW., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17292948/

Dose-escalation study of rivaroxaban (BAY 59-7939)--an ... This study demonstrated proof-of-principle for rivaroxaban for the prevention of VTE after total hip replacement surgery.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0049384807000102

Dose-escalation study of rivaroxaban (BAY 59-7939) – an ... The primary efficacy endpoint – deep vein thrombosis (DVT), pulmonary embolism (PE) or all-cause mortality – occurred in 22.2%, 23.8%, 20.0%, 10.2%, 17.4%, 15.1 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04444804

Study to Compare the Effectiveness of Rivaroxaban ... Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1007903

Oral Rivaroxaban for Symptomatic Venous ... Our studies show that rivaroxaban alone is as effective as standard therapy, with similar safety, for the treatment of acute DVT and that when ...

5. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.106.642074

A Once-Daily, Oral, Direct Factor Xa Inhibitor, Rivaroxaban ... Efficacy Outcomes​​ The primary efficacy end point (composite of any DVT, PE, and all-cause death) was observed in 14.9%, 10.6%, 8.5%, 13.5%, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2697099/

An Inside Look at the Oral Direct Factor Xa Inhibitor The primary safety outcome was major bleeding. The primary efficacy outcome was obser ved in 9.6% of the rivaroxaban patients and in 18.9% of the enoxaparin ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00396786?term=BAY%2059-7939&rank=10

Dose-ranging Study of Once-daily Regimen of BAY 59- ... The purpose of this study is to assess different doses of a new drug ( BAY 59 - 7939 ), taken as a tablet, are safe and can help prevent blood clots forming ...