drugset / Trial / NCT03570281

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

NCT03570281

Phase 2/3 Unknown 40 enrolled Samsung Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-06-15
Primary completion
2020-05-31
Completion
2020-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule 30 mg Oral
Subject Edoxaban Small molecule 60 mg Oral
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous

Indications

No indication recorded.