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Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

This study aims to compare the use of rivaroxaban, apixaban, and warfarin in patients who have completed 3-12 months of anticoagulation for acute venous thromboembolism (VTE) and require prolonged therapy. The study will evaluate the reduction of clinically relevant bleeding and the prevention of recurrent VTE associated with these oral anticoagulants.

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Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

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  1. Request for PCORnet Collaborators:Comparison of Oral Anticoagulants for extended VEnousThromboembolism (COVET) Lana Castellucci, David Garcia, and Thomas L. Ortel

  2. Background • LOI/Application Due Date • Accepting site requests at this time; planned date for enrollment of first patient is 1 October 2017 • Seeking interest from investigators at CDRNs for participation in a research study to answer the following questions: • In patients who have completed 3-12 months of anticoagulation for acute venous thromboembolism (VTE) and need prolonged therapy, are the direct oral anticoagulants rivaroxaban and/or apixaban superior to warfarin?

  3. Background • The minimal duration of anticoagulant therapy for an acute, unprovoked VTE is 3-6 months • Recurrent VTE occurs in up to 10% of patients in the first year after stopping anticoagulant therapy • The annual risk of major bleeding in patients who continue anticoagulant therapy is ~2% • Guidelines recommend continuing anticoagulation long-term if the risk for bleeding is “low” • Next crucial question: which anticoagulant is best?

  4. Study Objectives • For patients who have completed an initial 3-12 months of oral anticoagulant therapy for an acute, symptomatic VTE, who are continuing anticoagulant therapy, this study will: • 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 VTE • Determine if rivaroxabanis non-inferior to warfarin in the prevention of recurrent VTE • A secondary objective is the comparison of apixaban vs rivaroxaban for the prevention of clinically relevant bleeding and recurrent VTE

  5. Additional Aims • To engage patient groups and stakeholders to evaluate the burden of warfarin use (laboratory monitoring, drug/food interactions, frequency of dose adjustment, etc), and DOAC use (once vs. twice daily) • To assess adherence to medication

  6. Study Design: Patient Population • Inclusion criteria: • Adult patients, age 18 years or older • Confirmed symptomatic and unprovoked DVT/PE • Initial treatment with 3-12 months of oral anticoagulant • Considered by their primary provider to be at high risk of recurrent VTE • Exclusion criteria: • CrCl < 30 mL/min • Liver disease • Strong P-glycoprotein or CYP3A4 inducers/inhibitors • Life expectancy < 3 months

  7. Study Design: Treatment Regimens & Follow-up • Patients are randomized to one of three treatment options: • Warfarin, INR 2-3 • Rivaroxaban, 20 mg daily • Apixaban, 2.5 mg twice daily • Initial Encounter (site activities) • Obtain consent and release of information form for any potential outcome events during the study period • Obtain demographic information and patient history • Obtain medication history and review for any contraindicated medications at baseline • Initial physical examination

  8. COVET Trial Design • Follow-Up • Study participants will be followed for 12 months via structured telephone interviews at 1, 6, and 12 months • Follow-up calls will be conducted through a centralized Call Center • PROBE (Prospective Randomized Open Blinded End-point) • All outcome events centrally adjudicated by a blinded adjudication committee

  9. Collected Information & Outcome Measures • Primary Safety Endpoint • Clinically relevant bleeding • Major bleeding • Clinically relevant non-major bleeding • Primary Efficacy Endpoint • Recurrent VTE

  10. Collaboration with PCORnet Investigators and Sites • Explain your need from each collaborating site • Identification and screening of potentially eligible patients for study participation • Obtain informed consent on eligible patients who agree to participate and contact information for follow-up • Collect initial visit data (Call Center will take care of all follow-up data collection) • Specify short term and long term expectations from the collaborating investigator/sites. • We are asking each site to enroll a total of ~50 patients during the study enrollment period (~3 years)

  11. Benefits for Participating Sites • Participation in a clinical trial that will address a question that is important to patients on indefinite anticoagulant therapy following an unprovoked venous thromboembolic event • The site investigator at each participating institution that enrolls patients into the study will be included as a co-author on the primary manuscript as the COVET Investigators

  12. Questions?

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