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

Venous Thromboembolism Clinical Trial

— EPCAT II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720108
• Other study ID #: EPCATII.001
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2012
• Last updated: January 23, 2018
• Start date: February 24, 2013
• Est. completion date: July 2016

Study information

• Verified date: January 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3426
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• rivaroxaban and ASA

Locations

Country	Name	City	State
Canada	Capital Health	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
David Anderson	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic venous thromboembolism		up to 4 years
Primary	major or clinically relevant non-major bleeding		up to 4 years
Secondary	survival		up to 4 years
Secondary	myocardial infarction		up to 4 years
Secondary	stroke		up to 4 years
Secondary	wound infection		up to 4 years
Secondary	cost-effectiveness		up to 4 years