Back to resultsEdoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study) (ENCHASE)
Primary Purpose
Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Edoxaban
Enoxaparin
Sponsored by
About this trial
This is an interventional treatment trial for Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban) focused on measuring cancer-related stroke, coagulopathy, D-dimer, Edoxaban, enoxaparine
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
Sites / Locations
- Department of Neurology, Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Edoxaban group
Enoxaparin group
Arm Description
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.
Outcomes
Primary Outcome Measures
D-dimer change
interval change of serum D-dimer level between day 0 and 7
Secondary Outcome Measures
Surrogate endpoint
number of micro-embolic signal detected by transcranial doppler
Functional outcome
modified Rankin scale at 90 days, from 0 to 6, higher is worse
Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
symptomatic intracerebral hemorrhage major bleeding all-cause death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03570281
Brief Title
Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
Acronym
ENCHASE
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)
Keywords
cancer-related stroke, coagulopathy, D-dimer, Edoxaban, enoxaparine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Edoxaban group
Arm Type
Experimental
Arm Description
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.
Arm Title
Enoxaparin group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
D-dimer change
Description
interval change of serum D-dimer level between day 0 and 7
Time Frame
7 days after treatment
Secondary Outcome Measure Information:
Title
Surrogate endpoint
Description
number of micro-embolic signal detected by transcranial doppler
Time Frame
7 days after treatment
Title
Functional outcome
Description
modified Rankin scale at 90 days, from 0 to 6, higher is worse
Time Frame
90 days after enrollment
Title
Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
Description
symptomatic intracerebral hemorrhage major bleeding all-cause death
Time Frame
90 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Neurology, Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD PhD
Phone
82-2-3410-3599
Email
neuroboy50@naver.com
First Name & Middle Initial & Last Name & Degree
Jong-Won Chung, MD MSc
Phone
82-2-3410-3599
Email
neurocjw@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)
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