stop_circleTerminated/Withdrawn

Prophylaxis, Thromboembolism, Venous, Total Knee Replacement, Total Hip Replacement

Bayer Identifier:

15871

ClinicalTrials.gov Identifier:

NCT01523418

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to observe safety of Xarelto in VTE prophlylaxis after elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

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

  • - Exclusion criteria must be read in conjunction with the local product information
    - 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

Trial summary

Enrollment Goal
0
Trial Dates
October 2014 - November 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many Locations, India

Primary Outcome

  • Safety related variables are bleeding events reported as major or non-major adverse events
    date_rangeTime Frame:
    3 months after the day of surgery
    enhanced_encryption
    Safety Issue:
    Yes
  • Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
    date_rangeTime Frame:
    3 months after the day of surgery
    enhanced_encryption
    Safety Issue:
    Yes
  • All cause mortality
    date_rangeTime Frame:
    3 months after the day of surgery
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Xarelto in the prophylaxis of post surgical venous thromboembolism after elective major orthopedic surgery or hip or knee in Indian patients
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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