This study is in progress, not accepting new patients

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

a study on Cancer, General Venous Thromboembolism Deep Vein Thrombosis Venous Thrombosis Pulmonary Embolism Blood Clot

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

Official Title

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

Details

Venous blood clots affect nearly a million Americans each year. Venous clots in the legs are called deep venous thrombosis (DVT) and are dangerous because they travel to the lungs where they cause blockages known as pulmonary emboli (PE). DVT and PE are called venous thromboemboli (VTE). Cancer is a risk factor with nearly 200,000 VTEs in cancer patients each year. The purpose of VTE treatment is to prevent the initial clot from spreading and to prevent new clots from forming. This is accomplished by thinning the blood, or anticoagulation. Without anticoagulation, VTEs recur and are often fatal.

Recently, the FDA has approved 4 new Direct Oral AntiCoagulants (DOACs) for preventing VTE recurrence. Few cancer patients were included in the efficacy trials, and practice guidelines fall silent on whether switching to DOAC therapy is advisable. To fill this knowledge gap, the Alliance Foundation Trials LLC, a research network of academic and community practices across the US, is conducting a pragmatic randomized effectiveness trial.

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The investigators will conduct a trial of 811 cancer patients followed for 6 months. The intervention strategy is DOAC therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is LMWH alone or with warfarin. Within each arm, patients can choose the agent they prefer based on side effects, drug interactions, and practical issues such as co-pays. The trial compares these two strategies in terms of treatment: 1) benefits based on VTE recurrence; 2) harms based on bleeding rates; 3) burdens based on patients' reports of their experiences; and 4) mortality rates.

The investigators hypothesize that the benefits, harms and burdens of DOAC treatment will be non-inferior to, or better than, usual care with LMWH/ warfarin among cancer patients. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

Keywords

Cancer, Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Blood Clot, Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa), Dabigatran (Pradaxa), Warfarin (Coumadin), Low molecular weight heparin (LMWH), Pulmonary Embolism, Thrombosis, Embolism, Thromboembolism, Venous Thrombosis, Enoxaparin, Dalteparin, PENTA, Warfarin, Rivaroxaban, Dabigatran, Apixaban, Edoxaban, Fondaparinux

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment
  • Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms
    • Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
  • Treating physician intends to put participant on anticoagulation therapy for at least three months.
  • Age >= 18 years
  • Platelet count is >= 50,000/mm3 (<= 7 days prior to enrollment)
  • CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)

You CAN'T join if...

  • Diagnosis of acute leukemia
  • Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
    • Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
    • Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
  • Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
  • Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
  • Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment

Locations

  • UCSF Medical Center - Mission Bay
    San Francisco California 94143 United States
  • VA Central California Fresno Medical Center
    Fresno California 93073 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance Foundation Trials, LLC.
Links
FDA Package Insert for Rivaroxaban (Xarelto) FDA Package Insert for Apixaban (Eliquis) FDA Package Insert for Edoxaban (Savaysa) FDA Package Insert for Dabigatran (Pradaxa) FDA Package Insert for Dalteparin (Fragmin) FDA Package Insert for Enoxaparin (Lovenox) FDA Package Insert for Fondaparinux (Arixtra) FDA Package Insert for Warfarin (Coumadin)
ID
NCT02744092
Study Type
Interventional
Participants
About 811 people participating
Last Updated