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

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

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism (VTE)

• Study Type: Observational
• Enrollment (Actual): 35756

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants treated with apixaban
Participants treated with warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2016
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: CV185-523

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No