Rivaroxaban + ASA for Hip Fracture

(HIPSTER-Pilot Trial)

Not yet recruiting at 2 trial locations

Overseen By Federico Germini, Doctor of Medicine

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: McMaster University

Must not be taking: P-gp inhibitors, CYP3A4 inducers

Disqualifiers: Pregnancy, Hepatic disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, rivaroxaban and ASA (a common pain reliever), to determine if they can better prevent heart problems and blood clots after hip fracture surgery. It targets patients who have undergone hip fracture surgery and experienced myocardial injury, indicated by elevated levels of the protein troponin. Participants will receive either this new drug combination or a standard treatment to compare effectiveness. Individuals who had hip surgery due to a fall or similar low-energy accident and have shown signs of heart injury might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are already on rivaroxaban and ASA, or if you are taking drugs that strongly interact with the study medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a combination of rivaroxaban and acetylsalicylic acid (ASA), also known as aspirin, is generally safe for patients who have undergone hip fracture surgery. Past studies tested this combination to prevent blood clots after surgery, and the results revealed no major safety differences between using rivaroxaban and ASA together and using other treatments, such as aspirin alone. This indicates that the combination is usually well-tolerated.

This combination has also been used for other conditions, demonstrating sufficient safety for doctors to recommend it. However, like any medication, side effects can occur, so healthcare professionals must monitor patients during treatment. Overall, evidence suggests that using rivaroxaban and ASA together has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Rivaroxaban with ASA for hip fracture patients because this approach targets blood clots in a novel way. Unlike traditional treatments like low-molecular-weight heparin or fondaparinux, which rely solely on standard anticoagulation, Rivaroxaban provides dual antithrombotic action when paired with ASA. This combination may offer extended protection against blood clots over 90 days, compared to the typical 30-day regimens, potentially reducing the risk of complications after surgery.

What evidence suggests that rivaroxaban plus ASA might be an effective treatment for preventing major cardiovascular events after hip fracture surgery?

This trial will compare the combination of rivaroxaban and acetylsalicylic acid (ASA) with standard VTE prophylaxis. Studies have shown that using rivaroxaban with ASA is promising for preventing blood clots in veins and arteries. Previous research found that this combination effectively reduced blood clots, known as venous thromboembolism (VTE), after surgeries like hip fractures. While both rivaroxaban and ASA work well individually, they might be even more effective together at reducing blood clots and heart issues post-surgery. This combination aims to prevent both types of clots that can occur after hip surgeries, which is crucial because arterial clots can lead to serious heart problems. Although this approach is still under study, early findings suggest it may offer strong protection against these complications. ^{1 2 3 4 6}

Who Is on the Research Team?

Federico Germini, Doctor of Medicine

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals aged 45 or older who have had hip fracture surgery and experienced a myocardial injury (elevated troponin levels). It aims to test if certain medications can prevent heart-related and blood clot complications after surgery.

Inclusion Criteria

I am over 45, had surgery for a hip fracture from a minor injury, and have heart muscle damage.

Exclusion Criteria

My kidney function is very low.

My care center uses ASA for blood clot prevention after hip fractures.

I do not have conditions or take medications that would interfere with the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either rivaroxaban 2.5 mg twice daily plus ASA 75-100 mg daily for 90 days or standard VTE prophylaxis with an anticoagulant for approximately 30 days

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of major cardiovascular events and treatment adherence

90 days

What Are the Treatments Tested in This Trial?

Interventions

• ASA
• Rivaroxaban

Trial Overview The study compares the effectiveness of rivaroxaban plus ASA against standard treatments in preventing cardiovascular events post-hip fracture surgery. Participants will be randomly assigned to receive either the combination treatment for 90 days or standard care for 30 days.

How Is the Trial Designed?

Group I: rivaroxaban plus ASA Active Control 1 Intervention

rivaroxaban 2.5mg twice daily plus ASA 75-100mg daily for 90 days

Group II: standard VTE prophylaxis with an anticoagulant Active Control 3 Interventions

Institution's standard of care for thromboprophylaxis with a low-dose anticoagulant for \~30 days (as per the standard of care). Regimens could include low-molecular-weight heparin, fondaparinux, or direct oral anticoagulant.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Collaborator

Trials

12

Recruited

17,500+

International Network of VENous Thromboembolism Clinical Research Networks

Collaborator

Trials

1

Recruited

650+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6819168/

Comparison of the Efficacy and Safety of Aspirin and ... The purpose of this study was to: (i) compare the incidence of VTE with aspirin and rivaroxaban for the prevention of VTE after hip fracture ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/63/NCT07228663/Prot_000.pdf

Rivaroxaban plus Acetylsalicylic Acid Versus Standard of ... A total of 100 participants aged ≥45 years who received hip fracture surgery and experienced a myocardial injury will be randomized to receive ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1712746

Aspirin or Rivaroxaban for VTE Prophylaxis after Hip ... Aspirin and rivaroxaban were similarly effective for preventing venous thromboembolism after either total hip or total knee arthroplasty. There ...

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02274-z

Rivaroxaban versus aspirin in prevention of venous ... There was no significant difference between aspirin and rivaroxaban in prevention of venous thromboembolism following total joint arthroplasty or hip fracture ...

5. ashpublications.org ashpublications.org/ashclinicalnews/news/3782/Aspirin-as-Effective-as-Rivaroxaban-for-Preventing

Aspirin as Effective as Rivaroxaban for Preventing VTE After ... Aspirin was non-inferior to rivaroxaban (p<0.001) but not superior (p=0.84) for the prevention of postoperative proximal DVT or PE. One death occurred in the ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0020138324006533

Early surgical care of the anticoagulated hip fracture ... In-patient mortality was 5.3 % (n = 60). Regression analysis indicated that mortality was dependent on a high ASA classification of 4 and the time to surgery, ...