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Antiplatelet Agent

Rivaroxaban + Aspirin for Blood Clot Prevention After Joint Surgery (EPCATIII Trial)

Phase 3
Recruiting
Led By Sudeep P Shivakumar, MD
Research Sponsored by Sudeep Shivakumar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Under 18 years of age
Concomitant use of drugs that are strong inhibitors of P-gp AND CYP3A4 (e.g., systemic treatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gp AND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test whether adding rivaroxaban to aspirin helps prevent venous thromboembolism better than aspirin alone in patients undergoing hip or knee replacement surgery.

Who is the study for?
This trial is for adults undergoing elective hip or knee replacement surgery without a history of significant liver disease, kidney failure, low platelets, recent major surgery, chronic high-dose aspirin use, potential pregnancy or breastfeeding. They must not have had a blood clot before and can't be on certain other medications.
What is being tested?
The study is testing whether taking Rivaroxaban along with aspirin is better at preventing blood clots after hip or knee replacement surgery compared to just taking aspirin alone. Participants will be randomly assigned to one of the two treatment groups.
What are the potential side effects?
Possible side effects include bleeding risks due to the anticoagulant nature of Rivaroxaban and aspirin. There may also be gastrointestinal issues like ulcers with aspirin use and potential allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 18 years old.
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I am not taking strong medication that affects drug processing in my body.
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I am not pregnant, breastfeeding, and I use effective birth control.
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I take more than 100 mg of aspirin daily.
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I have not had major surgery in the last 3 months.
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I need major surgery after joint replacement within 3 months.
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I have had a blood clot in my leg or lung before.
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I had a hip or leg fracture in the last 3 months, not due to surgery.
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My cancer has spread to other parts of my body.
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I have had or will have surgery on both hips, both knees, or both at the same time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bleeding
Venous thromboembolism
Secondary study objectives
Cost-effectiveness
Survival

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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

4Treatment groups
Experimental Treatment
Active Control
Group I: TKA-study armExperimental Treatment1 Intervention
Total Knee Arthroplasty: 14 days of aspirin
Group II: THA-study armExperimental Treatment1 Intervention
Total Hip Arthroplasty: 35 days of aspirin
Group III: TKA-control armActive Control1 Intervention
Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin
Group IV: THA-control armActive Control1 Intervention
Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin

Find a Location

Who is running the clinical trial?

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) NetworkNETWORK
11 Previous Clinical Trials
12,083 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
1,500 Patients Enrolled for Deep Vein Thrombosis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,512,684 Total Patients Enrolled
11 Trials studying Deep Vein Thrombosis
9,434 Patients Enrolled for Deep Vein Thrombosis
Sudeep ShivakumarLead Sponsor

Media Library

Acetylsalicylic acid 81 mg (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04075240 — Phase 3
Deep Vein Thrombosis Research Study Groups: TKA-study arm, TKA-control arm, THA-study arm, THA-control arm
Deep Vein Thrombosis Clinical Trial 2023: Acetylsalicylic acid 81 mg Highlights & Side Effects. Trial Name: NCT04075240 — Phase 3
Acetylsalicylic acid 81 mg (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075240 — Phase 3
~1137 spots leftby Dec 2025
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