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

NCT ID: NCT03570281

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2020-11-30

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.

Conditions

Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

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 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.

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Oh Young Bang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Oh Young Bang, MD PhD

Role: primary

neuroboy50@naver.com

82-2-3410-3599

Jong-Won Chung, MD MSc

Role: backup

neurocjw@gmail.com

82-2-3410-3599

References

Chung JW, Hwang J, Kim HJ, Seo WK, Ahn MJ, Saver JL, Bang OY. Edoxaban for the treatment of hypercoagulability and cerebral thromboembolism associated with cancer: A randomized clinical trial of biomarker targets. Int J Stroke. 2024 Jul;19(6):645-653. doi: 10.1177/17474930241239266. Epub 2024 Mar 21.

Reference Type: DERIVED

PMID: 38429253 (View on PubMed)

Other Identifiers

SMC 2017-11-163-007

Identifier Type: -

Identifier Source: org_study_id