AnticoagulationPhase 4NCT01884337

Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

A Phase 4 study testing Apixaban in people with Anticoagulation, run by Bristol-Myers Squibb at 20 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anticoagulation
What is being tested?: Apixaban
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 557 participants
Where: 20 sitesIndia
Study dates: 24 Mar 2015to 4 Jun 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

India20 sites

Local Institution
Ahmedabad, 380015
Local Institution
Ahmedabad, 380016
Local Institution
Ahmedabad, 380060
Local Institution
Alappuzha, 688005
Local Institution
Aurangabad, 431003
Local Institution
Bangalore, 560054
Local Institution
Chandigarh, 160012
Local Institution
Chennai, 600010
Local Institution
Delhi, 110029
Local Institution
Hyderabad, 500034
Local Institution
Kerala, 695011
Local Institution
Kozhikode, Kerala, 673008
Local Institution
Lucknow, 226003
Local Institution
Mohali, 160062
Local Institution
Mumbai, 400 022
Local Institution
Nagpur, 440003
Local Institution
Pune, 411001
Local Institution
Pune, 411004
Local Institution
Pune, 411005
Local Institution
Pune, 411013

Other trials in India

About this study

Official title: A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

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

Conditions: Anticoagulation
Being tested: Apixaban

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApixabanDrug
Also called Eliquis, BMS-562247

Study groups in NCT01884337
Study group	Role	What they receive
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 Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.
Measured: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 20154 Jun 2018

First posted24 Jun 2013 (estimated)
Study start24 Mar 2015
Primary completion4 Jun 2018
Study completion4 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnticoagulationStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 557 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01884337
Sponsor's protocol ID: CV185-158
Status last verified: Nov 2019
First submitted: 6 Jun 2013
Last updated: 29 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children
Prophylactic, Anticoagulation
RecruitingPhase 3
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
RecruitingPhase 3
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Bleeding Post Cardiac Surgery, Indication for Anticoagulation
Enrolling by invitationPhase 4
Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Mitral Regurgitation, Atrial Fibrillation
Recruiting
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Atrial Fibrillation, Oral Anticoagulation

All Anticoagulation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
ClinicalTrials.gov ID: NCT01884337
Acronym / sponsor ID: CV185-158
Conditions: Anticoagulation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 557 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 24 Mar 2015 (actual)
Primary completion: 4 Jun 2018 (actual)
Study completion: 4 Jun 2018 (actual)
First posted: 24 Jun 2013 (estimated)
Results: Posted 9 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Apixaban (2.5 mg)	Experimental	Drug: ApixabanApixaban 2.5 mg tablets by mouth twice daily, 12 days for TKR subjects or 35 days for THR subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ApixabanAlso: Eliquis, BMS-562247	Drug	Apixaban (2.5 mg)

Primary outcome

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
Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR
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

1 secondary outcome

Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days
Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

Results and safety

Results posted to the registry on 9 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Knee Replacement (TKR)	326	322
Total Hip Replacement (THR)	172	170

Primary outcome: 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

Time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR. Count of participants. Unit: Participants

Measure	Total Knee Replacement (TKR) n = 326	Total Hip Replacement (THR) n = 172
Major Bleeding	0	0
Clinically Relevant Non-Major Bleeding	0	1
Major or Clinically Relevant Non-Major Bleeding	0	1
Any Bleeding	0	1

Population analysed: All participants who received at least one dose of study drug during the Treatment Period

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs are assessed from Day 1 through Day 42 +/- 2 days for Total Knee Replacement Participants; AEs are assessed from Day 1 through Day 65 +/-2 days for Total Hip Replacement Participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TOTAL KNEE REPLACEMENT (TKR)	2 of 326 (0.6%)	23 of 326 (7.1%)	0 of 326
TOTAL HIP REPLACEMENT (THR)	0 of 172 (0%)	6 of 172 (3.5%)	0 of 172

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Anticoagulation

Recruiting
Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children
Prophylactic, Anticoagulation
RecruitingPhase 3
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
RecruitingPhase 3
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Bleeding Post Cardiac Surgery, Indication for Anticoagulation
Enrolling by invitationPhase 4
Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Mitral Regurgitation, Atrial Fibrillation
Recruiting
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Atrial Fibrillation, Oral Anticoagulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban in people with Anticoagulation, run by Bristol-Myers Squibb at 20 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01884337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019; AzTrials last refreshed its copy on 26 Oct 2026.