EHR Alerts for Blood Clot Prevention

(eVTE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Scott C. Woller, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Scott C. Woller, MD

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Low creatinine clearance, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low. The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.

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 data supports the effectiveness of the drug rivaroxaban for preventing blood clots?

Rivaroxaban has been shown to be more effective than enoxaparin in preventing blood clots after hip or knee replacement surgery, with a lower rate of clot-related events and similar safety in terms of bleeding risk. It has been tested in large clinical trials involving over 24,000 patients, demonstrating its potential as a reliable alternative to traditional blood thinners like warfarin. ^{1 2 3 4 5}

Is rivaroxaban generally safe for humans?

Rivaroxaban has been shown to have a similar safety profile to other treatments for preventing blood clots, with no significant increase in major bleeding events. It has been studied in many patients and found to be well-tolerated, with no major cardiovascular or liver issues. ^{1 2 6 7 8}

How does the drug rivaroxaban differ from other treatments for blood clot prevention?

Rivaroxaban is unique because it is an oral medication that directly inhibits Factor Xa, a key protein in the blood clotting process, allowing for simplified once-daily dosing without the need for regular blood monitoring, unlike traditional treatments like warfarin which require frequent dose adjustments and monitoring. ^{1 2 3 4 9}

Research Team

Scott C. Woller, MD

Principal Investigator

Intermountain Health

Eligibility Criteria

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 am 18 years old or older.

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

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

Exclusion Criteria

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

My kidneys are functioning well enough for treatment.

Pregnant during encounter

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Business School

John (Jack) Lawrence

Janssen Pharmaceuticals

Chief Medical Officer since 2023

MD from University of Virginia School of Medicine

Findings from Research

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 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, 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]

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]

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 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]

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]

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]

References

1. Germany 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. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Rivaroxaban, an oral direct factor Xa inhibitor. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

6. New Zealand 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. [2022]

7. England 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. [2022]

8. Netherlands 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. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism. [2018]