Clinical trial NCT03570281: Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
Official title: Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)
Keywords: cancer-related stroke
coagulopathy
D-dimer
Edoxaban
enoxaparine
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults over 20 years old
* Acute cerebral infarction within 30 days of symptom onset was confirmed by diffusion-weighted brain magnetic resonance imaging (DWI)
* Cancer-related stroke, not diagnosed with other classic (arteriosclerosis, cardioembolicm, small-vessel occlusion, etc.) cerebral infarction, within six months of diagnosis, chemotherapy, surgery for cancer.
* with informed consent from the patient or next-of-kin, When the subject becomes able to decide whether to participate in the study, the researcher acquires further consent directly from the subject.

Exclusion Criteria:

* Patients with primary intracranial malignancy
* Patients with classic causes of cerebral infarction
* Patients with infectious or immunological disease that may affect blood D-dimer levels
* Patients whose cerebral infarction is thought to be caused by tumor (vascular occlusion due to tumor tissue)
* Patients who can not use anticoagulants with thrombocytopenia (platelet \<50,000), anemia (hemoglobin \<8)
* Decreased renal function (creatine clearance \<15 mL / mim)
* Patients who received intravenous tissue plasminogen activator
* Patients with uncontrolled severe hypertension
* Patients who received prosthetic heart valve replacement requiring anticoagulation
* Patients with moderate to severe mitral stenosis
* Pulmonary embolism requiring hemodynamically unstable or thrombolysis or pulmonary embolization
* Pregnant and lactating women
* Patients who are hypersensitive to the major component or constituent of the test drug
* Patients with liver diseases associated with blood clotting disorders and clinically significant bleeding risks

Primary outcomes:
measure: D-dimer change
timeFrame: 7 days after treatment
Secondary outcomes:
measure: Surrogate endpoint
timeFrame: 7 days after treatment
measure: Functional outcome
timeFrame: 90 days after enrollment
measure: Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
timeFrame: 90 days after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Samsung Medical Center
Study officials:
References: