Intracranial hemorrhage in Glioma Patients with Venous Thromboembolism after Conversion from Low Molecular Weight Heparin to Apixaban

Inclusion Criteria

• Patients must be 18 years of age or older
• Patients must have had a pathologically confirmed supra-tentorial primary brain tumor
• Patients must have a history of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
• Patients must have been treated with low molecule weight heparin (LMWH) for >= 5 days
• Patients must be able to provide written informed consent
• Patients must have non contrast CT that is negative for intra-cranial bleed at least 5 days post Initiation of LMWH and prior to initiation (within 7 days) of apixaban
• Must be decision by the patient and his physician to convert to apixaban
• Subjects who transition from dual antiplatelet therapy to monotherapy prior to enrollment will be eligible for the study

Exclusion Criteria

• Patients with a plan of less than 6 months of anticoagulation for most recent DVT or PE
• Patients with allergic reaction to apixaban
• Patients with active bleeding or high risk for bleeding contraindicating treatment with LMWH
• Patients with planned surgery in the next 2 weeks
• Patients previously treated with apixaban
• Patients requiring aspirin (ASA) > 165 mg/day at enrollment
• Patients requiring dual anti-platelet therapy (ASA plus clopidogrel or ASA plus ticagrelor or ASA plus prasugrel) at enrollment. Subjects who transition for dual anti-platelet therapy to monotherapy prior to enrollment will be eligible for the study
• Patients who are compulsorily detained for treatment of either a psychiatric or physical illness
• Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study
• Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study protocol
• Known active and clinically significant liver disease (e.g., hepatorenal syndrome)
• Known bacterial endocarditis
• Known uncontrolled hypertension: systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg; (subjects who have a transient, higher blood pressure elevation associated with acute PE [upper limit: systolic blood pressure 200 mm Hg or diastolic blood pressure 100 mm Hg] may enter the study;) elevated blood pressure that is persistent 1 - 2 days after the index DVT or PE should be treated according to local guidelines)
• Known intraocular bleeding or gastrointestinal bleeding and/or endoscopically verified ulcer disease in the last 6 months from start of apixaban
• Known head trauma or other major trauma and/or major surgery in the last 30 days prior to start of apixaban
• Known ischemic stroke or planned neurosurgery in the next 14 days prior to start of apixaban
• Known gross hematuria, or intracranial arteriovenous malformation or aneurysm, or overt major bleeding or documented hemorrhagic tendencies of blood dyscrasias at the start of apixaban
• Known evidence of poor healing of a major wound or major trauma or planned major surgery during trial