UnknownPhase 2/3

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

South Korea40 participantsStarted 2018-06-15

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 hypersensitiv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

D-dimer change

Timeframe: 7 days after treatment

Trial details

NCT IDNCT03570281

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-31

View on ClinicalTrials.gov More Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban) trials