Hip Fracture Surgery Arterial and Venous Thrombotic Events Prevention
NCT ID: NCT07228663
Last Updated: 2025-11-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-01
Study Completion Date
2027-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Hip Fracture Surgery
Cardiovascular Prevention
Venous Thromboembolism (VTE)
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Statisticians.
Study Groups
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rivaroxaban plus ASA
rivaroxaban 2.5mg twice daily plus ASA 75-100mg daily for 90 days
Group Type
ACTIVE_COMPARATOR
rivaroxaban and ASA
Intervention Type
DRUG
rivaroxaban 2.5 mg orally BID and ASA 75-100 mg OD for 90 days
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.
Group Type
ACTIVE_COMPARATOR
Low-molecular weight heparin
Intervention Type
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
Fondaparinux
Intervention Type
DRUG
2.5 mg subcutaneously OD
Direct Oral Anticoagulant (DOAC)
Intervention Type
DRUG
Rivaroxaban 10 mg OD or apixaban 2.5 mg BID, started after surgery or after a period of LMWH.
Interventions
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rivaroxaban and ASA
rivaroxaban 2.5 mg orally BID and ASA 75-100 mg OD for 90 days
Intervention Type
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
Intervention Type
DRUG
Fondaparinux
2.5 mg subcutaneously OD
Intervention Type
DRUG
Direct Oral Anticoagulant (DOAC)
Rivaroxaban 10 mg OD or apixaban 2.5 mg BID, started after surgery or after a period of LMWH.
Intervention Type
DRUG
Other Intervention Names
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acetylsalicylic acid
Xarelto
enoxaparin
dalteparin
tinzaparin
arixtra
rivaroxaban
apixaban
Eligibility Criteria
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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.
Minimum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
NETWORK
Sponsor Role
collaborator
International Network of VENous Thromboembolism Clinical Research Networks
UNKNOWN
Sponsor Role
collaborator
McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Federico Germini
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Federico Germini, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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St.Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Site Status
Juravinski Hospital
Hamilton, Ontario, Canada
Site Status
Humanitas Research Hospital
Milan, , Italy
Site Status
Countries
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Canada
Italy
Central Contacts
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Bambie Levoy-Jones, Honours Bachelor of Science
Role: CONTACT
905-525-9140 ext. 24928
Facility Contacts
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References
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Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.
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Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
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Gao Y, Long A, Xie Z, Meng Y, Tan J, Lv H, Zhang L, Zhang L, Tang P. The compliance of thromboprophylaxis affects the risk of venous thromboembolism in patients undergoing hip fracture surgery. Springerplus. 2016 Aug 18;5(1):1362. doi: 10.1186/s40064-016-2724-1. eCollection 2016.
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00781
Regulatory Decision Summary for Xarelto - Drug and Health Products Portal
https://www.ema.europa.eu/en/medicines/human/EPAR/xarelto#authorisation-details
Xarelto \| European Medicines Agency (EMA)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf
Food and Drug Administration (FDA). XARELTO (rivaroxaban) Label
Other Identifiers
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HIPSTER-2024
Identifier Type: -
Identifier Source: org_study_id
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