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

Venous Thromboembolism (VTE) Clinical Trial

Official title:

Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521908
• Other study ID #: CV185-523
• Status: Completed
• Start date: June 13, 2016
• Est. completion date: November 23, 2018

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35756
• Est. completion date: November 23, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major bleeding in participants treated with apixaban		2 years
Primary	Incidence of major bleeding in participants treated with warfarin		2 years
Secondary	Incidence of clinically relevant non-major bleeding event in participants treated with apixaban		2 years
Secondary	Incidence of clinically relevant non-major bleeding event in participants treated with warfarin		2 years
Secondary	Incidence of recurrent VTE in participants treated with apixaban		2 years
Secondary	Incidence of recurrent VTE in participants treated with warfarin		2 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form