Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for

Submitted by aschwalb on Thu, 08/10/2017 - 14:17
Study ID
DFCI 16-406
Trial Conditions New
Study Information

Participants will be randomized (like flipping a coin) to one of two arms:

Arm 1 - anticoagulation therapy with a low molecular weight heparin (LMWH)
alone or followed by warfarin (the usual approach).
Arm 2 - anticoagulation therapy with a direct oral anticoagulant (DOAC) (the “study approach”).
All of the medications used in this study have already been FDA-approved to treat blood clots. Therapy with a DOAC is already FDA-approved for use as anticoagulation
therapy, but DOACs have not been studied extensively in patients with cancer.
This study will allow the researchers to gather information about whether
anticoagulation therapy with a LMWH alone or followed by warfarin is better, the
same, or worse than anticoagulation therapy with a DOAC in patients with
cancer.

Contact Information

Wendy Loeser RN OCN
Clinical Research
Dana-Farber Cancer Institute at
St. Elizabeth's Medical Center
736 Cambridge St
Boston, MA 02135
617-789-3385
Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
Are you a cancer patient who has recently developed a blood clot?

The purpose of this study is to compare two
different approaches to anticoagulation therapy in patients with cancer.
Phase
3
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Eligibility

 Your doctor intends you to be on anticoagulation therapy for at least 3 months.
 Your blood counts meet the study criteria

 You are 21 years of age or older

 You are willing to be randomly assigned (like a flip of a coin) to one of two groups

You may not be eligible to participate if:

 You have acute leukemia

 You have ever received or are scheduled to receive a stem cell transplant

 You are pregnant or nursing