Comparing Rivaroxaban with acetylsalicylic acid (ASA) for hip fractures
Official title: HIP Fracture Oral ThromboPROphylaxis (Hip PRO Pilot)
HIP Fracture Oral ThromboPROphylaxis: a Pilot Randomized Controlled Trial (Hip PRO Pilot)
- Phase 2
- 2 groups
- Sites in Calgary, New Westminster and 1 more city
- Recruiting
Interventions
- Medication
Rivaroxaban 10mg
Rivaroxaban 10mg daily for 35 days post hip fracture surgery
- Medication
acetylsalicylic acid (ASA) 81mg Oral Tablet
acetylsalicylic acid (ASA) 81mg daily for 35 days post hip fracture surgery
Canadian Sites (3)
1 of 3 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
- Not yet recruiting
Royal Columbian Hospital
New Westminster, British Colombia
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 50 years with a hip fracture (AO-OTA classification 31-A1-A3 and 31-B1-B3) amenable to surgical treatment (presentation to hospital within 24 hours of injury). Patients with additional injuries will be included and any additional injuries will be documented.
- +Patients aged 50 years or older with an acute hip fracture (presentation to hospital within 24 hours of injury) that requires surgical treatment will be approached for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in the study:
- +Both open and closed fractures will be included, and open fractures will be documented.
- +Patients on single agent anti-platelet therapy (i.e., acetylsalicylic acid or clopidogrel) will be included.
- +Signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or surrogate consent to participate in study.
Exclusion
- −Contraindication to ASA use (allergy, documented gastrointestinal ulcer within the past year, severe thrombocytopenia \[platelet count \<50 x109/L at the time of hospital admission\]).
- −Contraindication to rivaroxaban use (allergy, acute renal failure \[CrCl \<30 mL/min\]).
- −Delayed presentation (over 24 hours between hip fracture and presentation to hospital).
- −Pathological fractures secondary to primary cancer or metastatic bone disease.
- −Peri-prosthetic femur fractures.
- −Received more than two doses of any thromboprophylaxis agent post-operatively, prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Pre-hospital therapeutic intensity antithrombotic therapy, including LMWH, Warfarin, DOACs, clopidogrel/ticagrelor, or chronic ASA use of any dose in the three months prior to hip fracture.
- −Known inherited bleeding or clotting disorder (factor V Leiden gene mutation, prothrombin gene mutation, protein C or protein S deficiency, antithrombin deficiency).
- −Intracranial hemorrhage requiring serial CT scans of the brain and/or surgical intervention.
- −Participant or surrogate unable to or unwilling to provide consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or complete follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Or surrogate consent not available.
- −Under age 50 years (more likely high energy, multiple injuries).
- −Multiply injured patients who require prolonged thromboprophylaxis or delayed thromboprophylaxis initiation.
- −Patient unable to attend follow-up visits.
- −Currently incarcerated, at a correctional facility.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Rivaroxaban 10mg.
Registry label: A: Rivaroxaban 10mg
Group B receives acetylsalicylic acid (ASA) 81mg Oral Tablet.
Registry label: B: acetylsalicylic acid (ASA) 81mg daily
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 50 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 250 people.
The study is currently expected to finish around March 2026.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recruitment Rate — measured over 12 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05775965 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Rivaroxaban 10mgDrug
Rivaroxaban 10mg daily for 35 days post hip fracture surgery
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About acetylsalicylic acid (ASA) 81mg Oral TabletDrug
acetylsalicylic acid (ASA) 81mg daily for 35 days post hip fracture surgery
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 50 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 months.
The study as a whole is currently expected to finish around 2026-03-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 250 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Calgary, Alberta, Canada; New Westminster, British Colombia, Canada; Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
As our Canadian population ages, hip fractures in these older adults are becoming very common. The best treatment for the majority of these injuries is urgent treatment with surgery. However, the hip fracture itself, the surgery required, and the immobility following these injuries are all risk factors for developing blood clots in the legs (deep vein thrombosis or DVT) and blood clots in the lungs (pulmonary embolism or PE). These complications are a common cause of death in patients with hip fractures and often result in prolonged medical treatment and hospital stays. Patients with hip fractures who require surgery are traditionally given injectable blood thinners to help prevent blood clots; however, these medications are costly, may not be tolerated well, and can be difficult to take, as prescribed. Oral blood thinning medications are being used more commonly, but it is unknown which of these medications is the most effective in preventing blood clots in patients after a hip fracture. Thrombelastography (TEG) technology uses a small sample of blood to evaluate a person's clotting ability. Our research has used TEG technology to evaluate blood clotting risk after hip fracture surgery and the investigators have found that platelets may play an important role in abnormal blood clotting after a hip fracture. The investigators have also shown that acetylsalicylic acid (ASA or Aspirin) may help reduce the abnormal platelet hyperactivity associated with blood clotting. This medication warrants investigation for blood clot prevention after hip fracture. The investigators propose to directly compare different oral medication regimens after hip fracture surgery, in order to determine which is safest and most effective in preventing blood clots. Our multi-disciplinary research team includes physicians, surgeons, and scientists with experience evaluating different medications for blood clot prevention. Our results will help determine the best medical treatment for preventing DVT and PE, which will benefit patients with hip fractures worldwide.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.