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


N/A
18 Years
85 Years
Open (Enrolling)
Both
Cancer Patients First-ever Acute Ischemic Stroke

Thank you

Trial Information

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


Any adult patient with active systemic cancer diagnosed with acute ischemic stroke at the
main MSKCC campus or any of MSKCC's New York City outpatient centers within the prior two
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.

- First-ever acute ischemic stroke within the prior two 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Outcomes

Outcome Description:

The primary safety outcomes will consist of intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Lisa DeAngelis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-264

NCT ID:

NCT01763606

Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Cancer Patients First-ever Acute Ischemic Stroke
  • Enoxaparin
  • Aspirin
  • stroke
  • 12-264
  • Stroke
  • Cerebral Infarction

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920