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Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

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. Read our disclaimer for details. Identifier: NCT01763606
Recruitment Status : Completed
First Posted : January 9, 2013
Results First Posted : May 15, 2020
Last Update Posted : August 14, 2020
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cancer Patients First-ever Acute Ischemic Stroke Drug: Enoxaparin Drug: Aspirin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
Actual Study Start Date : December 18, 2012
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Enoxaparin
Patients assigned to enoxaparin.
Drug: Enoxaparin
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.

Experimental: Aspirin
Patients assigned to Aspirin.
Drug: Aspirin
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).

Primary Outcome Measures :
  1. Safety Outcomes [ Time Frame: 1 year ]
    Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death

  2. Feasibility Outcomes [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures :
  1. Number of Participants With or Without Recurrent Ischemic Stroke [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01763606

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United States, New Jersey
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
New York Presbyterian Hospital
New York, New York, United States, 10065
Columbia University
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
New York Presbyterian Hospital
Weill Medical College of Cornell University
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Principal Investigator: Lisa DeAngelis, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT01763606    
Other Study ID Numbers: 12-264
First Posted: January 9, 2013    Key Record Dates
Results First Posted: May 15, 2020
Last Update Posted: August 14, 2020
Last Verified: April 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors