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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-24

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rivaroxaban

rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients

Group Type ACTIVE_COMPARATOR

rivaroxaban and ASA

Intervention Type DRUG

ASA

ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients

Group Type EXPERIMENTAL

rivaroxaban and ASA

Intervention Type DRUG

Interventions

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rivaroxaban and ASA

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No