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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
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
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
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
1,373 Previous Clinical Trials
26,513,842 Total Patients Enrolled
11 Trials studying Deep Vein Thrombosis
9,434 Patients Enrolled for Deep Vein Thrombosis
Sudeep ShivakumarLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.I have liver disease or another condition that prevents me from taking rivaroxaban.You have previously taken part in the EPCAT III study.I am not taking strong medication that affects drug processing in my body.I need long-term blood thinners due to a health condition or a clot after surgery.I am not pregnant, breastfeeding, and I use effective birth control.I take more than 100 mg of aspirin daily.I was diagnosed with COVID-19 in the last 3 months.I have received blood thinners after surgery.I have not had major surgery in the last 3 months.I am scheduled for elective hip or knee replacement surgery at a participating hospital.You are expected to live for less than 6 months.I need major surgery after joint replacement within 3 months.You are allergic to aspirin or currently have a stomach problem that makes it unsafe for you to take aspirin.Your platelet count is less than 100 x 10^9 per liter before surgery.Your kidneys do not filter waste from your blood very well.I have had a blood clot in my leg or lung before.I had a hip or leg fracture in the last 3 months, not due to surgery.My cancer has spread to other parts of my body.You have a history of serious bleeding that makes it unsafe for you to take blood thinning medication.I have had or will have surgery on both hips, both knees, or both at the same time.You are allergic to food dye.
Research Study Groups:
This trial has the following groups:- Group 1: TKA-study arm
- Group 2: TKA-control arm
- Group 3: THA-study arm
- Group 4: THA-control arm
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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