Clinical trial NCT01763606: Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
Official title: A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients First-ever Acute Ischemic Stroke
Keywords: Enoxaparin
Aspirin
stroke
12-264
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Weill Medical College of Cornell University
First posted: 2013-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety Outcomes
timeFrame: 1 year
measure: Feasibility Outcomes
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With or Without Recurrent Ischemic Stroke
timeFrame: 6 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center at Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lisa DeAngelis, MD
role: PRINCIPAL_INVESTIGATOR
References: