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Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

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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

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 22, 2017
Results First Submitted Date  ICMJE July 26, 2019
Results First Posted Date  ICMJE August 14, 2019
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • 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))
  • Number of Subjects With Recurrent Venous Thromboembolism (VTE) [ Time Frame: Randomization to 12 months ]
    Primary efficacy outcome of recurrent VTE
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • Clinically Relevant Bleeding Event [ Time Frame: Randomization to 12 months ]
    Primary safety event Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
  • Recurrent Venous Thromboembolism (VTE) [ Time Frame: Randomization to 12 months ]
    Primary efficacy outcome of recurrent VTE
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • All-cause mortality [ Time Frame: Randomization to 12 months ]
    All cause mortality
  • Major Bleeding [ Time Frame: Randomization to 12 months ]
    Major bleeding
  • Clinically relevant non-major bleeding [ Time Frame: Randomization to 12 months ]
    Clinically relevant non-major bleeding
  • Premature termination of study medication [ Time Frame: Randomization to 12 months ]
    Premature termination of study medication
  • Vascular events (myocardial infarction, ischemic stroke, peripheral arterial embolism) [ Time Frame: Randomization to 12 months ]
    MI, ischemic stroke, peripheral arterial embolism
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2019)
  • Number of Subjects Experiencing Major Bleeding [ Time Frame: Randomization to 12 months ]
    Major bleeding
  • Number of Subjects Experiencing Clinically Relevant Non-major Bleeding [ Time Frame: Randomization to 12 months ]
    Clinically relevant non-major bleeding
  • Number of Subjects With Premature Termination of Study Medication [ Time Frame: Randomization to 12 months ]
    Premature termination of study medication
  • Number of Subjects Experiencing All-cause Mortality [ Time Frame: Randomization to 12 months ]
    All cause mortality
  • Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke) [ Time Frame: Randomization to 12 months ]
    MI, ischemic stroke, peripheral arterial embolism
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism
Official Title  ICMJE Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)
Brief Summary Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE
  • Drug: Warfarin
    Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3
  • Drug: Apixaban 2.5 MG
    Will be randomized to receive open label apixaban of 2.5 mg twice daily
  • Drug: Rivaroxaban 10 MG
    Will be randomized to receive open label rivaroxaban of 10mg daily
Study Arms  ICMJE
  • Active Comparator: Warfarin
    Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3
    Intervention: Drug: Warfarin
  • Active Comparator: Apixaban
    Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily
    Intervention: Drug: Apixaban 2.5 MG
  • Active Comparator: Rivaroxaban
    Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily
    Intervention: Drug: Rivaroxaban 10 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
44
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
3165
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03196349
Other Study ID Numbers  ICMJE Pro00077510
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Thomas Ortel, MD Duke University
PRS Account Duke University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP