Hip Fracture Surgery Arterial and Venous Thrombotic Events Prevention (HIPSTER-Pilot)

November 13, 2025 updated by: Federico Germini, McMaster University

Rivaroxaban Plus Acetylsalicylic Acid Versus Standard of Care for Arterial and Venous Cardiovascular Prevention After Hip Fracture Surgery in Patients With Myocardial Injury: a Pilot Randomized Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bambie Levoy-Jones, Honours Bachelor of Science
  • Phone Number: 24928 905-525-9140
  • Email: levoyjob@mcmaster.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Hospital
        • Contact:
          • Flavia Kessler Borges, Doctor of Medicine
          • Phone Number: 40654 905-527-4322
          • Email: kesslerf@mcmaster.ca
        • Principal Investigator:
          • Flavia Kessler Borges, Doctor of Medicine
      • Hamilton, Ontario, Canada, L8N 4A6
        • St.Joseph's Healthcare Hamilton
        • Contact:
        • Principal Investigator:
          • James Douketis, Doctor of Medicine
  • Italy
      • Milan, Italy
        • Humanitas Research Hospital
        • Contact:
        • Principal Investigator:
          • Corrado Lodigiani, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rivaroxaban plus ASA
rivaroxaban 2.5mg twice daily plus ASA 75-100mg daily for 90 days
Drug: rivaroxaban and ASA
rivaroxaban 2.5 mg orally BID and ASA 75-100 mg OD for 90 days
Other Names:
  • acetylsalicylic acid
  • Xarelto
Active Comparator: standard VTE prophylaxis with an anticoagulant
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
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
Other Names:
  • enoxaparin
  • dalteparin
  • tinzaparin
Drug: Fondaparinux
2.5 mg subcutaneously OD
Other Names:
  • arixtra
Drug: Direct Oral Anticoagulant (DOAC)
Rivaroxaban 10 mg OD or apixaban 2.5 mg BID, started after surgery or after a period of LMWH.
Other Names:
  • apixaban
  • rivaroxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Through study completion, an average of 1 year.
Number of patients recruited per month per site
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FUP completion
Time Frame: assessed at 30 and 90 days
Proportion of patients with a complete follow up
assessed at 30 and 90 days
Treatment adherence
Time Frame: 30 and 90 days for the intervention, pre-specified treatment duration as per standard of care for the control.
Proportion of number of days on treatment
30 and 90 days for the intervention, pre-specified treatment duration as per standard of care for the control.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality, MI, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic objectively confirmted VTE
Time Frame: From randomization to 90 days post-randomization.
Composite. Also each individual component will be assessed.
From randomization to 90 days post-randomization.
Cardiovascular mortality
Time Frame: From randomization to 90 days post-randomization.
From randomization to 90 days post-randomization.
Major bleeding events
Time Frame: From randomization to 90 days post-randomization.
Major bleeding events as defined by the ISTH.
From randomization to 90 days post-randomization.
Clinically relevant nonmajor bleeding
Time Frame: From randomization to 90 days post-randomization.
From randomization to 90 days post-randomization.
Minor bleeding
Time Frame: From randomization to 90 days post-randomization.
From randomization to 90 days post-randomization.
Bleeding independently associated with mortality after non-cardiac surgery (BIMS)
Time Frame: From randomization to 90 days post-randomization.
Bleeding leading to a postoperative haemoglobin <70 g/L, transfusion of 1 unit of red blood cells, or bleeding that was judged to be the cause of death.
From randomization to 90 days post-randomization.
Quality of life (EQ-5D-5L)
Time Frame: 90 days
Measured with EQ-5D-5L
90 days
Hospitalizations
Time Frame: From randomization to 90-days post randomization.
The length of stay and re-hospitalizations as measures of resource utilization.
From randomization to 90-days post randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
International Network of VENous Thromboembolism Clinical Research Networks

Investigators

  • Principal Investigator: Federico Germini, Doctor of Medicine, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 16, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPSTER-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Available to share upon reasonable request, but will likely not unblind before completing a full-scale trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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