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VTE Prevention Following Total Hip and Knee Arthroplasty (EPCATIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075240
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Information provided by (Responsible Party):
Sudeep Shivakumar, Nova Scotia Health Authority

Brief Summary:
Consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg Drug: acetylsalicylic acid 81 mg Phase 3

Detailed Description:

Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone.

This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5400 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: randomized, controlled, double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: over-encapsulated rivaroxaban/ASA
Primary Purpose: Prevention
Official Title: Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: THA-control arm
Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin
Drug: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
Other Name: Xarelto 10mg and aspirin 81mg

Experimental: THA-study arm
Total Hip Arthroplasty: 35 days of aspirin
Drug: acetylsalicylic acid 81 mg
Starting post op, aspirin for 9 days for TKA and 30 days for THA
Other Name: aspirin 81mg

Active Comparator: TKA-control arm
Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin
Drug: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg
Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
Other Name: Xarelto 10mg and aspirin 81mg

Experimental: TKA-study arm
Total Knee Arthroplasty: 14 days of aspirin
Drug: acetylsalicylic acid 81 mg
Starting post op, aspirin for 9 days for TKA and 30 days for THA
Other Name: aspirin 81mg




Primary Outcome Measures :
  1. Venous thromboembolism [ Time Frame: 90 days ]
    symptomatic proximal deep vein thrombosis or pulmonary embolism

  2. Bleeding [ Time Frame: 90 days ]
    major and clinically relevant, non-major bleeds


Secondary Outcome Measures :
  1. Survival [ Time Frame: 90 days ]
    all cause death

  2. Cost-effectiveness [ Time Frame: 90 days ]
    quantitatively describe the costs of symptomatic thromboembolism events and major bleeding episodes



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study
  2. Written informed consent in accordance with federal, local and institutional guidelines

Exclusion Criteria:

  1. Previous documented VTE (proximal DVT or any PE)
  2. Hip or lower limb fracture in the previous three months, not related to present surgery
  3. Metastatic cancer
  4. Life expectancy less than 6 months
  5. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
  6. History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin
  7. History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban
  8. Creatinine clearance less than 15 ml per minute
  9. Pre-operative platelet count less than 100 x 109 /L
  10. Need for long-term anticoagulation due to a pre-existing co-morbid condition or due to the development of VTE following surgery but prior to randomization
  11. Received anticoagulation post operatively
  12. Bilateral THA/TKA or simultaneous hip and knee arthroplasty
  13. Major surgical procedure within the previous 3 months
  14. Requirement for major surgery post arthroplasty within a 90 day period
  15. Chronic daily aspirin use with dose greater than 100 mg a day
  16. Women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period
  17. Unwilling or unable to give consent
  18. Previous participation in the EPCAT III study
  19. Under 18 years of age
  20. 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)
  21. Known allergy to food dye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075240


Contacts
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Contact: Susan L Pleasance, BScN 902-473-7585 susan.pleasance@nshealth.ca

Sponsors and Collaborators
Sudeep Shivakumar
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Investigators
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Principal Investigator: Sudeep P Shivakumar, MD Dalhousie University/Nova Scotia Health Authority
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Responsible Party: Sudeep Shivakumar, Dr. Sudeep Shivakumar, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT04075240    
Other Study ID Numbers: EPCATIII.001
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sudeep Shivakumar, Nova Scotia Health Authority:
total hip and knee arthroplasty
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants