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VTE Prevention Following Total Hip and Knee Arthroplasty (EPCATIII)

Primary Purpose

Venous Thromboembolism

Status

Recruiting

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Rivaroxaban 10 MG and acetylsalicylic acid 81 mg

acetylsalicylic acid 81 mg

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring total hip and knee arthroplasty

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Previous documented VTE (proximal DVT or any PE)
Hip or lower limb fracture in the previous three months, not related to present surgery
Metastatic cancer
Life expectancy less than 6 months
History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin
History of significant hepatic disease or any other condition that in the judgment of the 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 to the 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 effective contraception 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., 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)
Known allergy to food dye
Diagnosis of COVID-19 in previous 3 months

Sites / Locations

Queen Elizabeth II HSCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

THA-control arm

THA-study arm

TKA-control arm

TKA-study arm

Arm Description

Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin

Total Hip Arthroplasty: 35 days of aspirin

Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin

Total Knee Arthroplasty: 14 days of aspirin

Outcomes

Primary Outcome Measures

Venous thromboembolism

symptomatic proximal deep vein thrombosis or pulmonary embolism

Bleeding

major and clinically relevant, non-major bleeds

Secondary Outcome Measures

Survival

all cause death

Cost-effectiveness

quantitatively describe the costs of symptomatic thromboembolism events and major bleeding episodes

Full Information

NCT ID

NCT04075240

First Posted

August 29, 2019

Last Updated

July 27, 2022

Sponsor

Sudeep Shivakumar

Collaborators

Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority, Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

1. Study Identification

Unique Protocol Identification Number

NCT04075240

Brief Title

VTE Prevention Following Total Hip and Knee Arthroplasty

Acronym

EPCATIII

Official Title

Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 4, 2021 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sudeep Shivakumar

Collaborators

Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority, Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism

Keywords

total hip and knee arthroplasty

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Sequential Assignment

Model Description

randomized, controlled, double-blind

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

over-encapsulated rivaroxaban/ASA

Allocation

Randomized

Enrollment

5400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

THA-control arm

Arm Type

Active Comparator

Arm Description

Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin

Arm Title

THA-study arm

Arm Type

Experimental

Arm Description

Total Hip Arthroplasty: 35 days of aspirin

Arm Title

TKA-control arm

Arm Type

Active Comparator

Arm Description

Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin

Arm Title

TKA-study arm

Arm Type

Experimental

Arm Description

Total Knee Arthroplasty: 14 days of aspirin

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban 10 MG and acetylsalicylic acid 81 mg

Other Intervention Name(s)

Xarelto 10mg and aspirin 81mg

Intervention Description

Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)

Intervention Type

Drug

Intervention Name(s)

acetylsalicylic acid 81 mg

Other Intervention Name(s)

aspirin 81mg

Intervention Description

Starting post op, aspirin for 9 days for TKA and 30 days for THA

Primary Outcome Measure Information:

Title

Venous thromboembolism

Description

symptomatic proximal deep vein thrombosis or pulmonary embolism

Time Frame

90 days

Title

Bleeding

Description

major and clinically relevant, non-major bleeds

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Survival

Description

all cause death

Time Frame

90 days

Title

Cost-effectiveness

Description

quantitatively describe the costs of symptomatic thromboembolism events and major bleeding episodes

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study Written informed consent in accordance with federal, local and institutional guidelines Exclusion Criteria: Previous documented VTE (proximal DVT or any PE) Hip or lower limb fracture in the previous three months, not related to present surgery Metastatic cancer Life expectancy less than 6 months History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin History of significant hepatic disease or any other condition that in the judgment of the 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 to the 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 effective contraception 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., 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) Known allergy to food dye Diagnosis of COVID-19 in previous 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susan L Pleasance, BScN

Phone

902-719-5203

susan.pleasance@nshealth.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sudeep P Shivakumar, MD

Organizational Affiliation

Dalhousie University/Nova Scotia Health Authority

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Elizabeth II HSC

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanne Douglas, BSc

Phone

902-473-7339

JoAnneE.Douglas@nshealth.ca

First Name & Middle Initial & Last Name & Degree

Glen Richardson, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

VTE Prevention Following Total Hip and Knee Arthroplasty

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