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Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

NCT ID: NCT03196349

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-05-01

Brief Summary

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Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.

Detailed Description

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Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Warfarin

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Apixaban

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Group Type ACTIVE_COMPARATOR

Apixaban 2.5 MG

Intervention Type DRUG

Will be randomized to receive open label apixaban of 2.5 mg twice daily

Rivaroxaban

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Group Type ACTIVE_COMPARATOR

Rivaroxaban 10 MG

Intervention Type DRUG

Will be randomized to receive open label rivaroxaban of 10mg daily

Interventions

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Warfarin

Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Intervention Type DRUG

Apixaban 2.5 MG

Will be randomized to receive open label apixaban of 2.5 mg twice daily

Intervention Type DRUG

Rivaroxaban 10 MG

Will be randomized to receive open label rivaroxaban of 10mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

To be eligible for this trial, patients must meet all of the following criteria:

* Have confirmed acute, symptomatic, first lower extremity proximal DVT and/or PE that is NOT associated with a transient risk factor.
* Have completed an initial treatment course of oral anticoagulant therapy for 3-12 months and have a recommendation from their provider to continue anticoagulation indefinitely.
* Have the capacity to understand and sign an informed consent form.
* Be 18 years of age and older.
* Under the direct care of a healthcare provider for treatment of VTE for the length of time in the study.

Exclusion Criteria

If a patient meets any of the following criteria, he or she may not be enrolled in the study:

* Creatinine clearance (CrCl) \< 30 mL/min as determined by Cockcroft-Gault formula documented within 3 months from date of consent
* Significant liver disease (Child-Pugh B or C)
* Concomitant use of medications that are strong P-glycoprotein or CYP3A4 inducers/inhibitors
* Another indication for chronic therapeutic-dose anticoagulation, such as atrial fibrillation (i.e., rivaroxaban, 10 mg daily, or apixaban, 2.5 mg twice daily, would not be appropriate therapy)
* A clinical indication for a specific anticoagulant regimen (e.g., warfarin with a target INR of 2-3 is recommended for patients with 'triple-positive' antiphospholipid syndrome).
* Life expectancy \< 3 months
* Currently pregnant or breast feeding
* Unable / unwilling to pay for one (or more) of the treatment options
* Active Cancer defined as:

Diagnosed with cancer within the past 6 months; or Recurrent, regionally advanced or metastatic disease; Currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or A hematologic malignancy not in complete remission

• Unwilling / unlikely to agree to follow up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Ortel, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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University of California Irvine Medical Center

Orange, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00077510

Identifier Type: -

Identifier Source: org_study_id