Anticoagulation in Cancer Related Stroke

Study Overview
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Brief Summary
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Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of cancer-related stroke, particularly in those without conventional stroke etiologies. Randomized clinical trials have investigated efficacy of vitamin K-dependent oral anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However, relatively little is known about the biological changes underlying intravascular coagulopathy and mechanisms of anticoagulation therapy in patients with cancer-related stroke. The aim of this study is to evaluate to determine the biological markers for intravascular coagulopathy causing stroke and for monitoring the effects of anticoagulation therapy, in patients with active cancer and stroke.

Official Title
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Optimal Anticoagulation Strategy In Stroke Related to CANCER (OASIS-CANCER Study)

Conditions
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Cancer, Stroke

Intervention / Treatment
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* Drug: Anticoagulation treatment.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 years and older Acute ischemic stroke presented within 7 days of symptom onset Cancer related stroke: active cancer (diagnosis of cancer within 6 months of stroke onset, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer) and ischemic stroke which could not be explained by conventional stroke mechanisms including large artery atherosclerosis, cardioembolism, lacunar infarction, or other etiologies (e.g., dissection) Signed informed consent or appropriate signed deferral of consent where approved Exclusion Criteria: Primary intracranial malignancy Incomplete workup for stroke etiology (either vascular or cardiologic studies) Any signs of infectious or immunological diseases which may influence plasma D-dimer levels Patients with stroke suspected to be caused by the tumor itself (i.e., tumor emboli) or cancer treatment (i.e., chemotherapy-induced stroke)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anticoagulation treatment.|Details of anticoagulation treatment information will be gathered including low molecular-weight heparin (enoxaparin 1 mg/kg) vs. NOAC (rivaroxaban 15 or 20 mg), vs. warfarin (target INR2.0-3.0) or no use of anticoagulation per physicians' decision and patients' conditions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke or systemic embolism | Recurrent stroke (development of neurologic deterioration or a new symptom/sign and relevant new cerebral lesions documented by a neuroimaging study) or systemic embolism (objectively documented, symptomatic, recurrent deep-vein thrombosis, pulmonary embolism, or both ). | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days modified Rankin Scale score |  | examined at 90 days after stroke symptom onset in each patients | 
| Effect of anticoagulation treatment | Effect of anticoagulation will be measured with D-dimer level during admission | up to 14 days | 
| Symptomatic hemorrhagic transformation | Symptomatic hemorrhagic transformation (newly developed cerebral hemorrhages that were temporally related to neurologic deterioration) or major bleeding up to 6 months (as defined by the International Society on Thrombosis and Haemostasis, J Thromb Haemost 2005;3:692-4) | up to 6 months |