Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

Completed · Not applicable

Conditions studied: Cancer Patients First-ever Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT01763606

Run by

Memorial Sloan Kettering Cancer Center

People needed

20

Starts

2012-12-18

Expected to finish

2019-04-03

Last updated by the study team

2020-08-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center at Commack — Commack, New York, United States
• Memorial Sloan Kettering West Harrison — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• Columbia University — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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