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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

October 30, 2012
March 11, 2014
February 2013
June 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01720108 on ClinicalTrials.gov Archive Site
  • 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 ]
  • survival [ Time Frame: up to 4 years ]
  • myocardial infarction [ Time Frame: up to 4 years ]
  • stroke [ Time Frame: up to 4 years ]
  • wound infection [ Time Frame: up to 4 years ]
  • cost-effectiveness [ Time Frame: up to 4 years ]
Not Provided
Not Provided
 
Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Venous Thromboembolism Prevention
Drug: rivaroxaban and ASA
  • Active Comparator: rivaroxaban
    rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
    Intervention: Drug: rivaroxaban and ASA
  • Experimental: ASA
    ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
    Intervention: Drug: rivaroxaban and ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3426
December 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Canada
 
NCT01720108
EPCATII.001
Yes
David Anderson, Capital District Health Authority, Canada
David Anderson
Canadian Institutes of Health Research (CIHR)
Principal Investigator: David R Anderson, MD Capital District Health Authority, Canada
Capital District Health Authority, Canada
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP