Anticoagulation in Cancer Related Stroke

NCT02743052 | Unknown

• 1 other identifier: SMC 2016-02-104
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 90-days modified Rankin Scale score

  examined at 90 days after stroke symptom onset in each patients

• Effect of anticoagulation treatment

  up to 14 days

• Symptomatic hemorrhagic transformation

  up to 6 months

Interventions

Anticoagulation treatment. DRUG

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute ischemic stroke patients with active cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135710, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oh Young Bang, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Won Chung, MD, MSc

CONTACT

82-2-3410-3599; neurocjw@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 19, 2016
• Study Start: October 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 19, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)