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OpenTrials
Completed

NCT Number: NCT01720108

Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty

In this study the investigators want to look at whether using aspirin instead of rivaroxaban (after initial treatment with rivaroxaban) works as well at preventing blood clots while also reducing risk of bleeding and is more cost effective in patients who have either a total hip replacement or total knee replacement.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Capital Health

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study

Exclusion criteria

  • Hip or lower limb fracture in the previous three months
  • 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 judgment of investigator precludes use of aspirin
  • History of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban
  • Creatinine clearance less than 30 ml per minute
  • Platelet count less than 100 x 109 /L
  • Need for long-term anticoagulation due to a preexisting co-morbid condition or due to the development of venous thromboembolism following surgery but prior to randomization
  • Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis
  • Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty
  • Major surgical procedure within the previous three months
  • Requirement for major surgery post arthroplasty within 90 day period
  • Chronic daily aspirin use with dose greater than 100 mg a day
  • Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period
  • Geographical inaccessibility for follow-up
  • Unwilling or unable to give consent
  • Previous participation in the study
  • Concomitant use with drugs that are strong inhibitors or inducers of both P-gp and CYP3A4

Treatment and study plan

rivaroxaban and ASA

Drug

Primary outcomes

  1. symptomatic venous thromboembolism

    Time frame: up to 4 years

  2. major or clinically relevant non-major bleeding

    Time frame: up to 4 years

Secondary outcomes

  1. survival

    Time frame: up to 4 years

  2. myocardial infarction

    Time frame: up to 4 years

  3. stroke

    Time frame: up to 4 years

  4. wound infection

    Time frame: up to 4 years

  5. cost-effectiveness

    Time frame: up to 4 years

Sponsors and collaborators

Lead sponsor

David Anderson

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: EPCAT II

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2012
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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