NCT02271399

Brief Summary

The purpose of this study is to compare the efficacy of two prophylactic agent(aspirin 300mg/day and rivaroxaban 10mg/day) for venous thromboembolism after total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

October 20, 2014

Last Update Submit

February 17, 2016

Conditions

Venous Thromboembolism

Keywords

venous thromboembolismtotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • venous thromboembolism

    Investigators evaluated the incidence of venous thromboembolism, including proximal and distal deep vein thrombosis, pulmonary embolism

    posteropertively 10days

Secondary Outcomes (1)

  • bleeding tendency

    2 days

Study Arms (2)

acetylsalicylic acid

ACTIVE COMPARATOR

aspirin 300mg tablet by mouth, every 24 hours for postoperatively 10 days

Drug: acetylsalicylic acid

rivaroxaban

EXPERIMENTAL

xarelto 10mg tablet by mouth, every 24 hours for postoperatively 10 days

Drug: rivaroxaban

Interventions

acetylsalicylic acidDRUG

300 mg aspirin(acetylsalicylic acid, AA, Bayer)/day was given orally for 10 days postoperatively.

Also known as: Aspirin(Bayer)
acetylsalicylic acid
rivaroxabanDRUG

xarelto 10mg(rivaroxaban, AA, Bayer)/day was given orally for 10 days postoperatively

Also known as: xarelto(bayer)
rivaroxaban

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients undergone primary total knee arthroplasty

You may not qualify if:

  • renal insufficiency, contrast allergy, simultaneous bilateral TKA, hemorrhagic disorder, sever liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery, Hanyang University, College of Medicine

Seoul, 133-792, South Korea

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

AspirinRivaroxaban

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiophenesSulfur CompoundsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Choonghyoek Choi

    Hanyang University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

KR(1)