Skip to main content
OpenTrials
Completed

NCT Number: NCT03521908

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of major bleeding in participants treated with apixaban

    Time frame: 2 years

  2. Incidence of major bleeding in participants treated with warfarin

    Time frame: 2 years

Secondary outcomes

  1. Incidence of clinically relevant non-major bleeding event in participants treated with apixaban

    Time frame: 2 years

  2. Incidence of clinically relevant non-major bleeding event in participants treated with warfarin

    Time frame: 2 years

  3. Incidence of recurrent VTE in participants treated with apixaban

    Time frame: 2 years

  4. Incidence of recurrent VTE in participants treated with warfarin

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 11, 2018
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.