NCT01884337

Brief Summary

The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
557

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

20 active sites

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

June 6, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 24, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 9, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

June 6, 2013

Results QC Date

June 3, 2019

Last Update Submit

November 26, 2019

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days

    TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours. CRNM bleeding is bleeding that 1\) Is clinically acute and overt 2) Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis

    2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Secondary Outcomes (1)

  • Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days

    2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Study Arms (1)

Apixaban (2.5 mg)

EXPERIMENTAL

Apixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Drug: Apixaban

Interventions

ApixabanDRUG
Also known as: Eliquis, BMS-562247
Apixaban (2.5 mg)

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative
  • Active bleeding or at high risk for bleeding.
  • Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery
  • Active hepatobiliary disease
  • Hemoglobin \<9 g/dL
  • Platelet count \<100,000/mm3
  • Creatinine clearance \<30 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Local Institution

Kozhikode, Kerala, 673008, India

Location

Local Institution

Ahmedabad, 380015, India

Location

Local Institution

Ahmedabad, 380016, India

Location

Local Institution

Ahmedabad, 380060, India

Location

Local Institution

Alappuzha, 688005, India

Location

Local Institution

Aurangabad, 431003, India

Location

Local Institution

Bangalore, 560054, India

Location

Local Institution

Chandigarh, 160012, India

Location

Local Institution

Chennai, 600010, India

Location

Local Institution

Delhi, 110029, India

Location

Local Institution

Hyderabad, 500034, India

Location

Local Institution

Kerala, 695011, India

Location

Local Institution

Lucknow, 226003, India

Location

Local Institution

Mohali, 160062, India

Location

Local Institution

Mumbai, 400 022, India

Location

Local Institution

Nagpur, 440003, India

Location

Local Institution

Pune, 411001, India

Location

Local Institution

Pune, 411004, India

Location

Local Institution

Pune, 411005, India

Location

Local Institution

Pune, 411013, India

Location

Related Links

MeSH Terms

Interventions

apixaban

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please email

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 24, 2013

Study Start

March 24, 2015

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

November 29, 2019

Results First Posted

September 9, 2019

Record last verified: 2019-11

Locations

IN(20)