Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days.
Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance \<30 mL/min), for 90 days.
Department of Neurology, Samsung Medical Center
Seoul, South Korea
RECRUITINGD-dimer change
interval change of serum D-dimer level between day 0 and 7
Time frame: 7 days after treatment
Surrogate endpoint
number of micro-embolic signal detected by transcranial doppler
Time frame: 7 days after treatment
Functional outcome
modified Rankin scale at 90 days, from 0 to 6, higher is worse
Time frame: 90 days after enrollment
Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
symptomatic intracerebral hemorrhage major bleeding all-cause death
Time frame: 90 days after enrollment
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