Anticoagulation in Cancer Related Stroke (OASIS-CANCER)

April 18, 2016 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Anticoagulation treatment.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of, 135710
    - Recruiting
    - Samsung Medical Center, Sungkyunkwan University School of Medicine
    - Contact:
      
      Jong-Won Chung, MD
      
      Phone Number: 82234101895
      
      Email: neurocjw@gmail.com
    - Sub-Investigator:
      
      Jong-Won Chung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute ischemic stroke patients with active cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent stroke or systemic embolism Time Frame: 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 ).	up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

Principal Investigator: Oh Young Bang, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)