We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anticoagulation in Cancer Related Stroke (OASIS-CANCER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02743052
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cancer Stroke Drug: Anticoagulation treatment.

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimal Anticoagulation Strategy In Stroke Related to CANCER (OASIS-CANCER Study)
Study Start Date : October 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ).


Secondary Outcome Measures :
  1. 90-days modified Rankin Scale score [ Time Frame: examined at 90 days after stroke symptom onset in each patients ]
  2. Effect of anticoagulation treatment [ Time Frame: up to 14 days ]
    Effect of anticoagulation will be measured with D-dimer level during admission

  3. 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)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute ischemic stroke patients with active cancer
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743052


Contacts
Contact: Jong-Won Chung, MD, MSc 82-2-3410-3599 neurocjw@gmail.com

Locations
Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135710
Contact: Jong-Won Chung, MD    82234101895    neurocjw@gmail.com   
Principal Investigator: Oh Young Bang, MD         
Sub-Investigator: Kwang Ho Lee, MD         
Sub-Investigator: Chin-Sang Chung, MD         
Sub-Investigator: Jong-Won Chung, MD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Oh Young Bang, MD, PhD Samsung Medical Center
More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02743052     History of Changes
Other Study ID Numbers: SMC 2016-02-104
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases