Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

Venous Thromboembolism Clinical Trial

— COVET  

Official title:

Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03196349
• Other study ID #: Pro00077510
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: December 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Warfarin
Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3
• Apixaban 2.5 MG
Will be randomized to receive open label apixaban of 2.5 mg twice daily
• Rivaroxaban 10 MG
Will be randomized to receive open label rivaroxaban of 10mg daily

Locations

Country	Name	City	State
United States	University of California Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects Experiencing Major Bleeding	Major bleeding	Randomization to 12 months
Other	Number of Subjects Experiencing Clinically Relevant Non-major Bleeding	Clinically relevant non-major bleeding	Randomization to 12 months
Other	Number of Subjects With Premature Termination of Study Medication	Premature termination of study medication	Randomization to 12 months
Other	Number of Subjects Experiencing All-cause Mortality	All cause mortality	Randomization to 12 months
Other	Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)	MI, ischemic stroke, peripheral arterial embolism	Randomization to 12 months
Primary	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
Primary	Number of Subjects With Recurrent Venous Thromboembolism (VTE)	Primary efficacy outcome of recurrent VTE	Randomization to 12 months