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

This study is ongoing, but not recruiting participants.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Anderson, Nova Scotia Health Authority Identifier:
First received: October 30, 2012
Last updated: January 30, 2017
Last verified: January 2017
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
Drug: rivaroxaban and ASA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 David Anderson, Nova Scotia Health Authority:

Primary Outcome Measures:
  • symptomatic venous thromboembolism [ Time Frame: up to 4 years ]
  • major or clinically relevant non-major bleeding [ Time Frame: up to 4 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3426
Actual Study Start Date: February 24, 2013
Estimated Study Completion Date: March 2017
Primary Completion Date: July 2016 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  19. Concomitant use with drugs that are strong inhibitors or inducers of both P-gp and CYP3A4
  Contacts and Locations
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Please refer to this study by its identifier: NCT01720108

Canada, Nova Scotia
Capital Health
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
David Anderson
Canadian Institutes of Health Research (CIHR)
Principal Investigator: David R Anderson, MD Nova Scotia Health Authority
  More Information

Responsible Party: David Anderson, Head, Department of Medicine, CDHA, Nova Scotia Health Authority Identifier: NCT01720108     History of Changes
Other Study ID Numbers: EPCATII.001
Study First Received: October 30, 2012
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants processed this record on May 25, 2017