NCT01720108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,426

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 24, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.4 years

First QC Date

October 30, 2012

Last Update Submit

January 23, 2018

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

  • symptomatic venous thromboembolism

    up to 4 years

  • major or clinically relevant non-major bleeding

    up to 4 years

Secondary Outcomes (5)

  • survival

    up to 4 years

  • myocardial infarction

    up to 4 years

  • stroke

    up to 4 years

  • wound infection

    up to 4 years

  • cost-effectiveness

    up to 4 years

Study Arms (2)

rivaroxaban

ACTIVE COMPARATOR

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

Drug: rivaroxaban and ASA

ASA

EXPERIMENTAL

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

Drug: rivaroxaban and ASA

Interventions

rivaroxaban and ASADRUG
ASArivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hip or lower limb fracture in the previous three months
  • Metastatic cancer
  • Life expectancy less than 6 months
  • History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
  • History of aspirin allergy, active peptic ulcer disease or gastritis that in judgment of investigator precludes use of aspirin
  • History of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban
  • Creatinine clearance less than 30 ml per minute
  • Platelet count less than 100 x 109 /L
  • 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
  • Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis
  • Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty
  • Major surgical procedure within the previous three months
  • Requirement for major surgery post arthroplasty within 90 day period
  • Chronic daily aspirin use with dose greater than 100 mg a day
  • Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (1)

  • Anderson DR, Dunbar M, Murnaghan J, Kahn SR, Gross P, Forsythe M, Pelet S, Fisher W, Belzile E, Dolan S, Crowther M, Bohm E, MacDonald SJ, Gofton W, Kim P, Zukor D, Pleasance S, Andreou P, Doucette S, Theriault C, Abianui A, Carrier M, Kovacs MJ, Rodger MA, Coyle D, Wells PS, Vendittoli PA. Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty. N Engl J Med. 2018 Feb 22;378(8):699-707. doi: 10.1056/NEJMoa1712746.

    PMID: 29466159DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David R Anderson, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Department of Medicine, CDHA

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 2, 2012

Study Start

February 24, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)