A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot
Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice
1 other identifier
observational
35,756
1 country
1
Brief Summary
A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2016
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedFebruary 28, 2022
February 1, 2022
2 years
April 30, 2018
February 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of major bleeding in participants treated with apixaban
2 years
Incidence of major bleeding in participants treated with warfarin
2 years
Secondary Outcomes (4)
Incidence of clinically relevant non-major bleeding event in participants treated with apixaban
2 years
Incidence of clinically relevant non-major bleeding event in participants treated with warfarin
2 years
Incidence of recurrent VTE in participants treated with apixaban
2 years
Incidence of recurrent VTE in participants treated with warfarin
2 years
Study Arms (2)
Participants treated with apixaban
Participants treated with warfarin
Eligibility Criteria
The study population will comprise all persons aged ≥18 years who received outpatient treatment with apixaban or warfarin within 30 days following their first observed encounter for VTE, and who met all other qualifying criteria.
You may qualify if:
- An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
- An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
- Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter
You may not qualify if:
- Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
- Evidence of VTE(VTE event)during 6-month period preceding index encounter
- Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 11, 2018
Study Start
June 13, 2016
Primary Completion
June 4, 2018
Study Completion
November 23, 2018
Last Updated
February 28, 2022
Record last verified: 2022-02