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Protocol No. UW17038
Principal Investigator Nazeef, Moniba
Age Group Adult
Sponsor Type Industry
Title Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
Objective The purpose of this study is to compare the benefits, harms, and burdens of two different approaches to anticoagulation (anti-clot) therapy in patients with cancer: the study approach: therapy with a direct oral anticoagulant (DOAC) or the usual approach: therapy with a low molecular weight heparin (LMWH) alone or followed by warfarin. There are several anticoagulation drugs (also called blood thinners or anti-clot drugs) approved by the U.S. Food and Drug Administration (FDA) that are commonly used to treat blood clots and to prevent additional blood clots. The usual approach typically involves low molecular weight heparin (LMWH) alone or followed by Warfarin (brand name Coumadin). Examples of commonly used low molecular weight heparins (LMWHs) are Dalteparin (Fragmin), Enoxaparin (Lovenox), or Fondaparinux (Arixtra).
Treatment All of the medications used in this study have already been FDA-approved to treat blood clots. This study has two study groups: Group 1 will get anticoagulation therapy with a DOAC. Group 2 will get anticoagulation therapy with a LMWH alone or followed by warfarin. A computer will by chance assign you to a treatment group in the study. This is called "randomization," and it is like flipping a coin. You will have an equal chance of being placed in either study Group 1 or Group 2. If you are randomized to Group 1, you will get anticoagulation therapy with a DOAC. If you are randomized to Group 2, you will get anticoagulation therapy with a LMWH alone or followed by warfarin (brand name Coumadin).
Description If placed in Group 1 your study doctor will prescribe one of the following anti-clot drugs: Rivaroxaban (brand name Xarelto), Apixaban/Eliquis, or Dabigatran (Pradaxa). These medications are all taken orally either once or twice a day depending on which drug you receive. If placed in Group 2, your study doctor will prescribe one of the following anti-clot drugs: Dalteparin (Fragmin), Enoxaparin (Lovenox), Fondaparinux (Arixtra), and may also prescribe you Warfarin (Coumadin). Warfarin is taken orally, whereas the other anti-clot drugs in this group (LMWHs) are injections. Subjects in both groups will take/administer these medications at home. In addition, all participants will receive treatment with study medications for approximately six months.
- Diagnosis of an advanced solid tumor, lymphoma, chronic lymphocytic leukemia (CLL), or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, chronic lymphocytic leukemia (CLL), 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
- Treating physician intends to put participant on anticoagulation therapy for at least three months
- Age ≥ 21 years
- Patients with a diagnosis of acute leukemia are excluded
- Patients who have ever received an autologous hemaopoietic stem cell transplantation are eligible
- Patients who are scheduled to receive an autologous hematopoietic stem cell transplantation are not eligible
- Patients with ongoing, clinically significant bleeding are not eligible
- Patients who need ongoing therapy with certain antifungals or certain seizure medications at the time of enrollment are not eligible
- Patients who are pregnant or nursing are not eligible
Applicable Disease Sites Breast; Colon and Rectum; Gastrointestinal cancers, other; Hematologic cancers, other; Lung; Lymphoma; Multiple Myeloma; Pancreas; Prostate
Drugs Involved Apixaban; Arixtra (Fondaparinux); Coumadin (Warfarin); Dabigatran; Dalteparin; Edoxaban; Eliquis (Apixaban); Enoxaparin; Fondaparinux; Fragmin (Dalteparin); Lovenox (Enoxaparin); Pradaxa (Dabigatran); Rivaroxaban; Savaysa (Edoxaban); Warfarin; Xarelto (Rivaroxaban)
Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park