Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study) (ENCHASE)

June 16, 2018 updated by: Oh Young Bang, Samsung Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Department of Neurology, Samsung Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edoxaban group
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.
Drug: Edoxaban
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.
Active Comparator: Enoxaparin group
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.
Drug: Enoxaparin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D-dimer change
Time Frame: 7 days after treatment
interval change of serum D-dimer level between day 0 and 7
7 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surrogate endpoint
Time Frame: 7 days after treatment
number of micro-embolic signal detected by transcranial doppler
7 days after treatment
Functional outcome
Time Frame: 90 days after enrollment
modified Rankin scale at 90 days, from 0 to 6, higher is worse
90 days after enrollment
Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage]
Time Frame: 90 days after enrollment
symptomatic intracerebral hemorrhage major bleeding all-cause death
90 days after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Anticipated)

May 31, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

June 16, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 16, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2017-11-163-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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