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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Capital District Health Authority, Canada
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Anderson, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01720108
First received: October 30, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism Prevention
Drug: rivaroxaban and ASA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • symptomatic venous thromboembolism [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • major or clinically relevant non-major bleeding [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • survival [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
  • wound infection [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3426
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rivaroxaban
rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
Drug: rivaroxaban and ASA
Experimental: ASA
ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
Drug: rivaroxaban and ASA

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hip or lower limb fracture in the previous three months
  2. Metastatic cancer
  3. Life expectancy less than 6 months
  4. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
  5. History of aspirin allergy, active peptic ulcer disease or gastritis that in judgment of investigator precludes use of aspirin
  6. History of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban
  7. Creatinine clearance less than 30 ml per minute
  8. Platelet count less than 100 x 109 /L
  9. 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
  10. Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis
  11. Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty
  12. Major surgical procedure within the previous three months
  13. Requirement for major surgery post arthroplasty within 90 day period
  14. Chronic daily aspirin use with dose greater than 100 mg a day
  15. Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period
  16. Geographical inaccessibility for follow-up
  17. Unwilling or unable to give consent
  18. Previous participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720108

Locations
Canada, Nova Scotia
Capital Health Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Susan Pleasance, BScN    902-473-7585    susan.pleasance@cdha.nshealth.ca   
Principal Investigator: Michael Dunbar, MD         
Sponsors and Collaborators
David Anderson
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: David R Anderson, MD Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: David Anderson, Head, Department of Medicine, CDHA, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01720108     History of Changes
Other Study ID Numbers: EPCATII.001
Study First Received: October 30, 2012
Last Updated: March 11, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014