A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot

Completed

• Conditions: Venous Thromboembolism (VTE)

• Registration Number: NCT03521908
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-13
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Primary Completion: 2018-06-04
• Study Completion: 2018-11-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35756

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major bleeding in participants treated with apixaban	2 years
Incidence of major bleeding in participants treated with warfarin	2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of recurrent VTE in participants treated with warfarin	2 years
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Princeton, New Jersey, United States