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Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196349
Recruitment Status : Terminated (Lack of enrollment)
First Posted : June 22, 2017
Results First Posted : August 14, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Warfarin Drug: Apixaban 2.5 MG Drug: Rivaroxaban 10 MG Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Warfarin
Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3
Drug: Warfarin
Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Active Comparator: Apixaban
Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily
Drug: Apixaban 2.5 MG
Will be randomized to receive open label apixaban of 2.5 mg twice daily

Active Comparator: Rivaroxaban
Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily
Drug: Rivaroxaban 10 MG
Will be randomized to receive open label rivaroxaban of 10mg daily




Primary Outcome Measures :
  1. Number of Subjects With Clinically Relevant Bleeding Events [ Time Frame: Randomization to 12 months ]
    Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))

  2. Number of Subjects With Recurrent Venous Thromboembolism (VTE) [ Time Frame: Randomization to 12 months ]
    Primary efficacy outcome of recurrent VTE


Other Outcome Measures:
  1. Number of Subjects Experiencing Major Bleeding [ Time Frame: Randomization to 12 months ]
    Major bleeding

  2. Number of Subjects Experiencing Clinically Relevant Non-major Bleeding [ Time Frame: Randomization to 12 months ]
    Clinically relevant non-major bleeding

  3. Number of Subjects With Premature Termination of Study Medication [ Time Frame: Randomization to 12 months ]
    Premature termination of study medication

  4. Number of Subjects Experiencing All-cause Mortality [ Time Frame: Randomization to 12 months ]
    All cause mortality

  5. Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke) [ Time Frame: Randomization to 12 months ]
    MI, ischemic stroke, peripheral arterial embolism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

3.1 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.

3.2 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196349


Locations
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United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
Duke University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Thomas Ortel, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Statistical Analysis Plan  [PDF] July 11, 2018
Study Protocol  [PDF] September 21, 2018
Informed Consent Form  [PDF] August 8, 2018


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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03196349    
Other Study ID Numbers: Pro00077510
First Posted: June 22, 2017    Key Record Dates
Results First Posted: August 14, 2019
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Rivaroxaban
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action