Anticoagulation in Cancer Related Stroke

Stroke Clinical Trial

— OASIS-CANCER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02743052
• Other study ID #: SMC 2016-02-104
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2016
• Last updated: April 18, 2016
• Start date: October 2009
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Samsung Medical Center
• Contact: Jong-Won Chung, MD, MSc
• Phone: 82-2-3410-3599
• Email: neurocjw[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	90-days modified Rankin Scale score		examined at 90 days after stroke symptom onset in each patients	No
Secondary	Effect of anticoagulation treatment	Effect of anticoagulation will be measured with D-dimer level during admission	up to 14 days	No
Secondary	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	Yes