Anticoagulation in Cancer Related Stroke

• Conditions: Cancer; Stroke

• Registration Number: NCT02743052
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Status Verified: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Study First Posted: 2016-04-19
• Last Update Posted: 2016-04-19
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrent stroke or systemic embolism	up to 6 months	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 ).

Secondary Outcome Measures

Name	Time	Method
90-days modified Rankin Scale score	examined at 90 days after stroke symptom onset in each patients
Symptomatic hemorrhagic transformation	up to 6 months	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)
Effect of anticoagulation treatment	up to 14 days	Effect of anticoagulation will be measured with D-dimer level during admission

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of