NCT01523418

Brief Summary

The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Typical duration for all trials

Status
withdrawn

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

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

January 30, 2012

Last Update Submit

February 2, 2016

Conditions

Prophylaxis, Thromboembolism, VenousTotal Knee ReplacementTotal Hip Replacement

Keywords

XareltoThromboembolism, VenousOrthopedic surgeryFactor Xa inhibitorObservational study

Outcome Measures

Primary Outcomes (3)

  • Safety related variables are bleeding events reported as major or non-major adverse events

    3 months after the day of surgery

  • Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events

    3 months after the day of surgery

  • All cause mortality

    3 months after the day of surgery

Study Arms (1)

Group 1

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

The treatment with Xarelto 10mg tablets should comply with the recommendations. Rivaroxaban 10mg OD, 6-10 hours post-op, provided hemostasis has been achieved, for a period of 2 weeks (TKR) \& 5 weeks (THR)

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective TKR / THR

You may qualify if:

  • Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis
  • Patients willing to give a written informed consent

You may not qualify if:

  • Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible.
  • Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ThromboembolismVenous Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02