VTE Prevention Following Total Hip and Knee Arthroplasty

NCT04075240 | Recruiting Phase 3 DMC

• 1 other identifier: EPCATIII.001
• Study Type: interventional
• Target: 5,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Keywords

total hip and knee arthroplasty

Outcome Measures

Primary Outcomes (2)

• Venous thromboembolism

  symptomatic proximal deep vein thrombosis or pulmonary embolism

  90 days

• Bleeding

  major and clinically relevant, non-major bleeds

  90 days

Secondary Outcomes (2)

• Survival

  90 days

• Cost-effectiveness

  90 days

Study Arms (4)

THA-control arm

ACTIVE COMPARATOR

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

Drug: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg

THA-study arm

EXPERIMENTAL

Total Hip Arthroplasty: 35 days of aspirin

Drug: acetylsalicylic acid 81 mg

TKA-control arm

ACTIVE COMPARATOR

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

Drug: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg

TKA-study arm

EXPERIMENTAL

Total Knee Arthroplasty: 14 days of aspirin

Drug: acetylsalicylic acid 81 mg

Interventions

Rivaroxaban 10 MG and acetylsalicylic acid 81 mg DRUG

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

Also known as: Xarelto 10mg and aspirin 81mg

THA-control arm; TKA-control arm

acetylsalicylic acid 81 mg DRUG

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

Also known as: aspirin 81mg

THA-study arm; TKA-study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sudeep Shivakumar: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Nova Scotia Health Authority: collaborator
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator

Study Sites (1)

Queen Elizabeth II HSC

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sudeep P Shivakumar, MD

  Dalhousie University/Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan L Pleasance, BScN

CONTACT

902-719-5203; susan.pleasance@nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: over-encapsulated rivaroxaban/ASA
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Division of Hematology

Model Details: randomized, controlled, double-blind

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: February 4, 2021
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)