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

NCT ID: NCT03521908

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35756 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-13

Study Completion Date

2018-11-23

Brief Summary

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

Detailed Description

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Conditions

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Venous Thromboembolism (VTE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants treated with apixaban

No interventions assigned to this group

Participants treated with warfarin

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV185-523

Identifier Type: -

Identifier Source: org_study_id

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