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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03521908

Enrollment

35756

Registered

2018-05-11

Start date

2016-06-13

Completion date

2018-11-23

Last updated

2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism (VTE)

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

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

Countries

United States

Outcome results