Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

NCT03196349 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00077510
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Clinically Relevant Bleeding Events

  Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))

  Randomization to 12 months

• Number of Subjects With Recurrent Venous Thromboembolism (VTE)

  Primary efficacy outcome of recurrent VTE

  Randomization to 12 months

Other Outcomes (5)

• Number of Subjects Experiencing Major Bleeding

  Randomization to 12 months

• Number of Subjects Experiencing Clinically Relevant Non-major Bleeding

  Randomization to 12 months

• Number of Subjects With Premature Termination of Study Medication

  Randomization to 12 months

Study Arms (3)

Warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Apixaban

ACTIVE COMPARATOR

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

Drug: Apixaban 2.5 MG

Rivaroxaban

ACTIVE COMPARATOR

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

Drug: Rivaroxaban 10 MG

Interventions

Warfarin DRUG

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

Warfarin

Apixaban 2.5 MG DRUG

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

Apixaban

Rivaroxaban 10 MG DRUG

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

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Warfarin; apixaban; Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Results Point of Contact

• Title: Dr. Thomas Ortel
• Organization: Duke University

thomas.ortel@duke.edu

919-684-5350 ext 3

Study Officials

• Thomas Ortel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: August 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 13, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-12

Locations

US (1)