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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Kozhikode | Kerala | 673008 | India | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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557 participants were enrolled, of whom 498 were treated. Of the 59 who were not treated, 42 no longer met study criteria, 6 withdrew consent, 11 due to other reasons. Of the 326 who started Total Knee Replacement, 324 continued into follow-up period and of the 172 who started Total Hip Replacement, 170 continued into follow-up period.
This study was conducted in an Indian orthopedic population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Knee Replacement (TKR) | Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks |
| FG001 | Total Hip Replacement (THR) | Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2014 | Jun 3, 2019 |
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| Ahmedabad |
| 380015 |
| India |
| Local Institution | Ahmedabad | 380016 | India |
| Local Institution | Ahmedabad | 380060 | India |
| Local Institution | Alappuzha | 688005 | India |
| Local Institution | Aurangabad | 431003 | India |
| Local Institution | Bangalore | 560054 | India |
| Local Institution | Chandigarh | 160012 | India |
| Local Institution | Chennai | 600010 | India |
| Local Institution | Delhi | 110029 | India |
| Local Institution | Hyderabad | 500034 | India |
| Local Institution | Kerala | 695011 | India |
| Local Institution | Lucknow | 226003 | India |
| Local Institution | Mohali | 160062 | India |
| Local Institution | Mumbai | 400 022 | India |
| Local Institution | Nagpur | 440003 | India |
| Local Institution | Pune | 411001 | India |
| Local Institution | Pune | 411004 | India |
| Local Institution | Pune | 411005 | India |
| Local Institution | Pune | 411013 | India |
| FDA Safety Alerts and Recalls | View source |
| Continuing Into Follow-up Period |
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| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Knee Replacement (TKR) | Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks |
| BG001 | Total Hip Replacement (THR) | Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All participants who received at least one dose of study drug during the Treatment Period | Posted | Count of Participants | Participants | 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR |
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| Secondary | 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. | All participants who received at least one dose of study drug | Posted | Count of Participants | Participants | 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TOTAL KNEE REPLACEMENT (TKR) | Oral administration of apixaban 2.5 mg twice daily (BID) for 2 weeks | 0 | 326 | 2 | 326 | 23 | 326 |
| EG001 | TOTAL HIP REPLACEMENT (THR) | Oral administration of apixaban 2.5 mg twice daily (BID) for 5 weeks | 0 | 172 | 0 | 172 | 6 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2018 | Jun 3, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C522181 | apixaban |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Major or Clinically Relevant Non-Major Bleeding |
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| Any Bleeding |
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