Enoxaparin Versus Aspirin in Patients With Cancer and Stroke



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:10/6/2018
Start Date:December 2012
End Date:December 2019

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

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.


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.
We found this trial at
7
sites
116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Basking Ridge, New Jersey 07920
Phone: 212-639-7997
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Basking Ridge, NJ
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Phone: 212-639-7997
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Lisa DeAngelis, M.D.
Phone: 212-639-7997
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10032
Principal Investigator: Randolph Marshall, MD
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New York, New York 10065
Phone: 212-639-7123
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New York, NY
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