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Hip Fracture SurgeryPhase 3HIPSTER-PilotNCT07228663

Hip Fracture Surgery Arterial and Venous Thrombotic Events Prevention

A Phase 3 study testing rivaroxaban and ASA, Low-molecular weight heparin and Fondaparinux in people with Hip Fracture Surgery and Cardiovascular Prevention, run by McMaster University at 3 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
rivaroxaban and ASA, Low-molecular weight heparin and Fondaparinux
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesin 2 countries
Study dates
1 Dec 2025to 1 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Federico Germini, Doctor of Medicine contact

905-525-9140

germinif@mcmaster.ca

Bambie Levoy-Jones, Honours Bachelor of Science contact

905-525-9140 ext. 24928

levoyjob@mcmaster.ca

3 sites in 2 countries

Canada2 sites

  • St.Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

    James Douketis, Doctor of Medicine, 905-521-6178, jdouket@mcmaster.ca

    James Douketis, Doctor of Medicine

  • Juravinski Hospital

    Hamilton, Ontario, L8V 1C3

    Flavia Kessler Borges, Doctor of Medicine, 905-527-4322 ext. 40654, kesslerf@mcmaster.ca

    Flavia Kessler Borges, Doctor of Medicine

Other trials in Canada

Italy1 site

  • Humanitas Research Hospital

    Milan

    Corrado Lodigiani, Doctor of Medicine, +39 0282244656, corrado.lodigiani@humanitas.it

    Corrado Lodigiani, Doctor of Medicine

Other trials in Italy

About this study

Official title: 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.

Being tested
rivaroxaban and ASA, Low-molecular weight heparin, Fondaparinux, Direct Oral Anticoagulant (DOAC)
Keywords
rivaroxaban, acetylsalicylic acid, cardiovascular prevention, hip fracture surgery, myocardial injury, venous thromboembolism (VTE)
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rivaroxaban and ASADrug

    Also called acetylsalicylic acid, Xarelto

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

  • Low-molecular weight heparinDrug

    Also called enoxaparin, dalteparin, tinzaparin

    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

  • FondaparinuxDrug

    Also called arixtra

    2.5 mg subcutaneously OD

  • Direct Oral Anticoagulant (DOAC)Drug

    Also called rivaroxaban, apixaban

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

Study groups in NCT07228663
Study groupRoleWhat they receive
rivaroxaban plus ASAActive comparatorrivaroxaban 2.5mg twice daily plus ASA 75-100mg daily for 90 days
Receives: Drug: rivaroxaban and ASA
standard VTE prophylaxis with an anticoagulantActive comparatorInstitution'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.
Receives: Drug: Low-molecular weight heparin; Drug: Fondaparinux; Drug: Direct Oral Anticoagulant (DOAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Number of patients recruited per month per site

    Measured: Through study completion, an average of 1 year.

Secondary outcomes (2)

  1. FUP completion

    Proportion of patients with a complete follow up

    Measured: assessed at 30 and 90 days

  2. Treatment adherence

    Proportion of number of days on treatment

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07228663
Sponsor's protocol ID
HIPSTER-2024
Acronym
HIPSTER-Pilot
Status last verified
Aug 2025
First submitted
16 Aug 2025
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Available to share upon reasonable request, but will likely not unblind before completing a full-scale trial.

Publications

  • 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.

    PubMed 29466159

  • Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.

    PubMed 19878532

  • Roshanov PS, Eikelboom JW, Sessler DI, Kearon C, Guyatt GH, Crowther M, Tandon V, Borges FK, Lamy A, Whitlock R, Biccard BM, Szczeklik W, Panju M, Spence J, Garg AX, McGillion M, VanHelder T, Kavsak PA, de Beer J, Winemaker M, Le Manach Y, Sheth T, Pinthus JH, Siegal D, Thabane L, Simunovic MRI, Mizera R, Ribas S, Devereaux PJ. Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study establishing diagnostic criteria and prognostic importance. Br J Anaesth. 2021 Jan;126(1):163-171. doi: 10.1016/j.bja.2020.06.051. Epub 2020 Aug 5.

    PubMed 32768179

  • Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.

    PubMed 28213598

  • National Guideline Centre (UK). Venous thromboembolism in over 16s: Reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism. London: National Institute for Health and Care Excellence (NICE); 2018 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK493720/

    PubMed 29697228

  • Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available.

    PubMed 36017553

  • Duceppe E, Parlow J, MacDonald P, Lyons K, McMullen M, Srinathan S, Graham M, Tandon V, Styles K, Bessissow A, Sessler DI, Bryson G, Devereaux PJ. Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment and Management for Patients Who Undergo Noncardiac Surgery. Can J Cardiol. 2017 Jan;33(1):17-32. doi: 10.1016/j.cjca.2016.09.008. Epub 2016 Oct 4.

    PubMed 27865641

  • Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Martinez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Astrakov SV, Rao M, Wu WKK, Bhatt K, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Whitlock RP, McGillion MH, Prystajecky M, Vincent J, Eikelboom J, Copland I, Balasubramanian K, Turan A, Bangdiwala SI, Stillo D, Gross PL, Cafaro T, Alfonsi P, Roshanov PS, Belley-Cote EP, Spence J, Richards T, VanHelder T, McIntyre W, Guyatt G, Yusuf S, Leslie K; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171. Epub 2022 Apr 2.

    PubMed 35363452

  • Douketis JD, Spyropoulos AC, Murad MH, Arcelus JI, Dager WE, Dunn AS, Fargo RA, Levy JH, Samama CM, Shah SH, Sherwood MW, Tafur AJ, Tang LV, Moores LK. Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline. Chest. 2022 Nov;162(5):e207-e243. doi: 10.1016/j.chest.2022.07.025. Epub 2022 Aug 11.

    PubMed 35964704

  • Sheth T, Natarajan MK, Hsieh V, Valettas N, Rokoss M, Mehta S, Jolly S, Tandon V, Bezerra H, Devereaux PJ. Incidence of thrombosis in perioperative and non-operative myocardial infarction. Br J Anaesth. 2018 Apr;120(4):725-733. doi: 10.1016/j.bja.2017.11.063. Epub 2017 Nov 21.

    PubMed 29576113

  • Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.

    PubMed 32222135

  • Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

    PubMed 15842354

  • 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.

    PubMed 28844192

  • Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

    PubMed 24679062

  • Devereaux PJ, Duceppe E, Guyatt G, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Vincent J, Franzosi MG, Srinathan SK, Erb J, Magloire P, Neary J, Rao M, Rahate PV, Chaudhry NK, Mayosi B, de Nadal M, Iglesias PP, Berwanger O, Villar JC, Botto F, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Sharma M, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Hoeft A, Yusuf S; MANAGE Investigators. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. doi: 10.1016/S0140-6736(18)30832-8.

    PubMed 29900874

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rivaroxaban and ASA, Low-molecular weight heparin and Fondaparinux in people with Hip Fracture Surgery and Cardiovascular Prevention, run by McMaster University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Federico Germini, Doctor of Medicine (905-525-9140, germinif@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07228663, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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