Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

Study Overview
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Brief Summary
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Patients with cancer who develop stroke are at high risk for future strokes or other clotting events. These patients are routinely treated with medicines that thin their blood, including enoxaparin or aspirin. However, it is unclear which medicine is best and whether these medicines can be adequately studied in a clinical trial. The purpose of this Phase I/II study is to determine if a clinical trial of different blood thinners in patients with cancer and stroke is possible. In addition, the study aims to compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with cancer and recent stroke.

Official Title
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A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

Conditions
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Cancer Patients First-ever Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Enoxaparin
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Any adult patient with active systemic cancer diagnosed with acute ischemic stroke at the main MSKCC campus or at any of MSKCC's New York City outpatient center WCMC, NYPH/CUMC within the prior four weeks would be eligible. Inclusion Criteria: 18 to 85 years of age. Active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months. A pathology report issued at the enrolling site confirming the diagnosis of cancer is required for enrollment. Acute ischemic stroke within the prior four weeks, defined as a new neurologic deficit(s) with MRI evidence of acute ischemia in a referable location, and no clinical or radiologic indication of a non-cerebrovascular mimic, such as a brain metastasis, as the etiology of the deficit(s). Exclusion Criteria: Inability to get brain MRI Known malignant primary brain tumor. Diagnosis of intracranial hemorrhage within the past 3 months, including intratumoral hemorrhage into brain metastases from a systemic cancer. Active or serious bleeding within two weeks of enrollment. Patient condition associated with a high risk of bleeding such as recent surgery or peptic ulcer disease. Clear indication for anticoagulation (e.g., atrial fibrillation) anticipated during the study period. Clear indication for antiplatelet agents (e.g., cardiac stents); a patient receiving aspirin for primary prevention prior to index stroke may be enrolled as long as study investigators believe it would be safe for the patient to stop aspirin if the patient was randomized to the enoxaparin arm. Active bleeding diathesis. Platelet count of ≤ 70,000/mm3, an international normalized ratio (INR) > 1.6, or a partial thromboplastin time (PTT) > 40 seconds. Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia. Serum creatinine > 2 mg/dl. AST or ALT > 200 U/L. Hemoglobin < 8 gm/dl Symptomatic carotid stenosis. Active pregnancy. Life expectancy < 1 month or current hospice care Unavailability for follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enoxaparin<br>Patients assigned to enoxaparin. | Drug: Enoxaparin<br>* Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.<br>|
| Experimental: Aspirin<br>Patients assigned to Aspirin. | Drug: Aspirin<br>* Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcomes | Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death | 1 year | 
| Feasibility Outcomes | The primary feasibility outcome is patient enrollment defined as the number of patients who enroll in the study divided by the number of patients who were eligible to enroll. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With or Without Recurrent Ischemic Stroke | Secondary efficacy outcomes will be assessed for and will include recurrent ischemic stroke, all strokes (ischemic or hemorrhagic), transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism, and systemic arterial thrombosis. Functional outcomes will also be evaluated, including the modified Rankin Scale score, the National Institute of Health Stroke Scale, and the Karnofsky Performance Status Scale. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enoxaparin, Aspirin, stroke, 12-264