CompletedNCT03521908Updated Feb 28, 2022

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

An observational study in Venous Thromboembolism (VTE), sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-28.

Sponsored by Bristol-Myers Squibb · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 35,756
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Venous Thromboembolism (VTE)

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In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 35,756 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

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Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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.

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

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 design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 35,756 participants (actual)
Patient registry: No

Groups and cohorts

Participants treated with apixaban
Participants treated with warfarin

What researchers measure

Primary outcomes

Incidence of major bleeding in participants treated with apixaban
Time frame: 2 years
Incidence of major bleeding in participants treated with warfarin
Time frame: 2 years

Secondary outcomes

Incidence of clinically relevant non-major bleeding event in participants treated with apixaban
Time frame: 2 years
Incidence of clinically relevant non-major bleeding event in participants treated with warfarin
Time frame: 2 years
Incidence of recurrent VTE in participants treated with apixaban
Time frame: 2 years
Incidence of recurrent VTE in participants treated with warfarin
Time frame: 2 years

Study locations

1 site

Local Institution
Princeton, New Jersey 08540, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03521908
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: May 11, 2018
Start date: Jun 13, 2016
Primary completion: Jun 4, 2018
Completion: Nov 23, 2018
Last update: Feb 28, 2022

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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