Last updated: February 6, 2024
Sponsor: Sudeep Shivakumar
Overall Status: Active - Recruiting
Phase
3
Condition
Venous Thromboembolism
Thromboembolism
Blood Clots
Treatment
acetylsalicylic acid 81 mg
Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
Clinical Study ID
NCT04075240
EPCATIII.001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients undergoing elective THA/TKA at the participating institutions will bepotentially eligible for this study
- Written informed consent in accordance with federal, local and institutionalguidelines
Exclusion
Exclusion Criteria:
- Previous documented VTE (proximal DVT or any PE)
- Hip or lower limb fracture in the previous three months, not related to presentsurgery
- Metastatic cancer
- Life expectancy less than 6 months
- History of major bleeding that in the judgment of the investigator precludes use ofanticoagulant prophylaxis
- History of aspirin allergy, active peptic ulcer disease or gastritis that in thejudgment of investigator precludes use of aspirin
- History of significant hepatic disease or any other condition that in the judgment ofthe investigator precludes the use of rivaroxaban
- Creatinine clearance less than 15 ml per minute
- Pre-operative platelet count less than 100 x 109 /L
- Need for long-term anticoagulation due to a pre-existing co-morbid condition or due tothe development of VTE following surgery but prior to randomization
- Received anticoagulation post operatively
- Bilateral THA/TKA or simultaneous hip and knee arthroplasty
- Major surgical procedure within the previous 3 months
- Requirement for major surgery post arthroplasty within a 90 day period
- Chronic daily aspirin use with dose greater than 100 mg a day
- Women of childbearing potential who are not abstinent or do not use effectivecontraception or are breast-feeding throughout the study drug period
- Unwilling or unable to give consent
- Previous participation in the EPCAT III study
- Under 18 years of age
- Concomitant use of drugs that are strong inhibitors of P-gp AND CYP3A4 (e.g., systemictreatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gpAND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John'sWort)
- Known allergy to food dye
Study Design
Total Participants: 5400
Treatment Group(s): 2
Primary Treatment: acetylsalicylic acid 81 mg
Phase: 3
Study Start date:
February 04, 2021
Estimated Completion Date:
April 30, 2026
Study Description
Connect with a study center
Queen Elizabeth II HSC
Halifax, Nova Scotia B3H 3A7
CanadaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.