Hip Fracture Surgery Arterial and Venous Thrombotic Events Prevention

NCT07228663 | Not Yet Recruiting Phase 3

• 1 other identifier: HIPSTER-2024
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

A third of patients undergoing surgery for a hip fracture develop a myocardial injury (i.e., an elevated troponin measurement), and these patients are at substantial risk of death and morbidity. Current prophylaxis strategies focus on preventing venous thromboembolism (VTE); however, arterial events are more common and carry a poor prognosis. The association of acetylsalicylic acid (ASA) 75-100 mg once daily and rivaroxaban 2.5 mg twice a day (the regimen used in the COMPASS trial) might prevent both VTE and arterial cardiovascular events. Among patients who have undergone hip fracture surgery and have evidence of myocardial injury, to explore the feasibility of a randomized controlled trial (RCT) comparing rivaroxaban 2.5 mg twice daily + low-dose ASA (75-100 mg) for 90 days, with standard VTE thromboprophylaxis for 30 days, for prevention of major cardiovascular events. The HIPSTER-Pilot is a multicenter, international, open-label, pilot RCT with blinded outcome adjudication. A total of 100 participants aged ≥45 years who received hip fracture surgery and experienced a myocardial injury will be randomized to 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 30 days. The primary feasibility outcome will be the recruitment rate. Other feasibility measures include completeness of follow-up and adherence to the treatment. Exploratory clinical outcomes will be assessed. This pilot trial will provide information on the feasibility of conducting a larger RCT to evaluate the efficacy and safety of the COMPASS regimen for preventing arterial and venous thrombotic events after hip fracture surgery in patients who have had myocardial injury. The results of this feasibility study will inform the design of the full-scale trial.

Conditions

Hip Fracture Surgery; Cardiovascular Prevention; Venous Thromboembolism (VTE)

Keywords

rivaroxaban; acetylsalicylic acid; cardiovascular prevention; hip fracture surgery; myocardial injury; venous thromboembolism (VTE)

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  Number of patients recruited per month per site

  Through study completion, an average of 1 year.

Secondary Outcomes (2)

• FUP completion

  assessed at 30 and 90 days

• Treatment adherence

  30 and 90 days for the intervention, pre-specified treatment duration as per standard of care for the control.

Other Outcomes (8)

• all-cause mortality, MI, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic objectively confirmted VTE

  From randomization to 90 days post-randomization.

• Cardiovascular mortality

  From randomization to 90 days post-randomization.

• Major bleeding events

  From randomization to 90 days post-randomization.

Study Arms (2)

rivaroxaban plus ASA

ACTIVE COMPARATOR

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

Drug: rivaroxaban and ASA

standard VTE prophylaxis with an anticoagulant

ACTIVE COMPARATOR

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.

Drug: Low-molecular weight heparin; Drug: Fondaparinux; Drug: Direct Oral Anticoagulant (DOAC)

Interventions

rivaroxaban and ASA DRUG

rivaroxaban 2.5 mg orally BID and ASA 75-100 mg OD for 90 days

Also known as: acetylsalicylic acid, Xarelto

rivaroxaban plus ASA

Low-molecular weight heparin DRUG

Enoxaparin: 40 mg subcutaneously OD (or 30 mg subcutaneously BID); Dalteparin: 5000 IU subcutaneously OD (or alternative dosing based on institutional protocol); Tinzaparin: 4500 IU subcutaneous OD

Also known as: enoxaparin, dalteparin, tinzaparin

standard VTE prophylaxis with an anticoagulant

Fondaparinux DRUG

2.5 mg subcutaneously OD

Also known as: arixtra

standard VTE prophylaxis with an anticoagulant

Direct Oral Anticoagulant (DOAC) DRUG

Rivaroxaban 10 mg OD or apixaban 2.5 mg BID, started after surgery or after a period of LMWH.

Also known as: rivaroxaban, apixaban

standard VTE prophylaxis with an anticoagulant

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥45 years, received surgery for a hip fracture due to a low-energy mechanism, and myocardial injury (i.e., an elevated troponin measurement).

You may not qualify if:

• Centers in which standard of care for VTE prophylaxis after hip fractures is ASA, alone or in combination with other drugs; patients with GFR \<15mL/min; patients with drug interactions and conditions that prevent the use of the standard of care or intervention \[Known allergy to the study drugs; pregnancy; an indication for anticoagulation, for dual antiplatelet therapy, for a P2Y12 inhibitor; already on rivaroxaban 2.5 mg twice daily + ASA before the fracture; bleeding diathesis that in the judgment of the investigator precludes the use of anticoagulant prophylaxis; history of significant hepatic disease (Child-Pugh B or C, see supplementary material) or any other condition that, in the judgment of the investigator, precludes the use of rivaroxaban; concomitant use of drugs that are strong inhibitors or strong inducers of P-glycoprotein (P-gp, e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus \[HIV\]-protease inhibitors, such as ritonavir) and/or Cytochrome P450 3A4 (CYP3A4)\]; expected requirement for major surgery post-arthroplasty within 90 days; women Persons of childbearing potential who are not abstinent or do not use appropriate contraception or are breast-feeding; unable or unwilling to provide consent; previous participation in the HIPSTER trial; participation in another anticoagulant or antiplatelet study.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator
• International Network of VENous Thromboembolism Clinical Research Networks: collaborator

Study Sites (3)

St.Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Humanitas Research Hospital

Milan, Italy

Location

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Related Links

• Regulatory Decision Summary for Xarelto - Drug and Health Products Portal
• Xarelto \| European Medicines Agency (EMA)
• Food and Drug Administration (FDA). XARELTO (rivaroxaban) Label

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Aspirin; Dalteparin; Enoxaparin; Tinzaparin; Fondaparinux; N(4)-oleylcytosine arabinoside; apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Oligosaccharides

Study Officials

• Federico Germini, Doctor of Medicine

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Germini, Doctor of Medicine

CONTACT

905-525-9140; germinif@mcmaster.ca

Bambie Levoy-Jones, Honours Bachelor of Science

CONTACT

905-525-9140; levoyjob@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statisticians.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A total of 100 participants aged ≥45 years who received hip fracture surgery and experienced a myocardial injury will be randomized to 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 \~30 days, as per the standard of care.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: November 14, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-08

Locations

IT (1); CA (2)