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Antiplatelet Agent

Oral Blood Thinners for Hip Fracture (HIP PRO Pilot Trial)

Phase 3
Waitlist Available
Led By Prism S Schneider, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare different oral blood thinning medications to find the safest + most effective treatment to prevent blood clots after hip fracture surgery. It will benefit patients with hip fractures worldwide.

Who is the study for?
This trial is for adults aged 50 or older who have a hip fracture that needs surgery and got to the hospital within 24 hours of injury. They can be on low-dose anti-platelet therapy like aspirin. People with cancer-related fractures, those who can't follow up, took lots of blood thinners post-injury, or have certain bleeding/clotting disorders can't join.
What is being tested?
The study compares oral blood thinners Rivaroxaban (10mg) and ASA (81mg) in preventing blood clots after hip fracture surgery. It aims to find out which one is safer and more effective using TEG technology to monitor clotting ability.
What are the potential side effects?
Possible side effects include bleeding risks, allergic reactions to the medications, potential gastrointestinal issues with ASA use such as ulcers, and kidney problems if there's pre-existing renal failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recruitment Rate
Secondary study objectives
Arterial thromboembolism events
Bleeding complications
Complete Blood Counts
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: acetylsalicylic acid (ASA) 81mg dailyExperimental Treatment1 Intervention
acetylsalicylic acid (ASA) 81mg daily for 35 days post hip fracture surgery
Group II: Rivaroxaban 10mgExperimental Treatment1 Intervention
Rivaroxaban 10mg daily for 35 days post hip fracture surgery

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,133 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,823 Total Patients Enrolled
Prism S Schneider, MD, PhDPrincipal InvestigatorUniversity of Calgary

Media Library

Acetylsalicylic acid (ASA) 81mg Oral Tablet (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05775965 — Phase 3
Trochanteric Fractures Research Study Groups: Rivaroxaban 10mg, acetylsalicylic acid (ASA) 81mg daily
Trochanteric Fractures Clinical Trial 2023: Acetylsalicylic acid (ASA) 81mg Oral Tablet Highlights & Side Effects. Trial Name: NCT05775965 — Phase 3
Acetylsalicylic acid (ASA) 81mg Oral Tablet (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05775965 — Phase 3
~36 spots leftby Mar 2025
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