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Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

Primary Purpose

Cancer Patients First-ever Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Aspirin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Patients First-ever Acute Ischemic Stroke focused on measuring Enoxaparin, Aspirin, stroke, 12-264

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Enoxaparin

Aspirin

Arm Description

Patients assigned to enoxaparin.

Patients assigned to Aspirin.

Outcomes

Primary Outcome Measures

Safety Outcomes
Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death
Feasibility Outcomes
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

Number of Participants With or Without Recurrent Ischemic Stroke
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.

Full Information

First Posted
December 20, 2012
Last Updated
August 6, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York Presbyterian Hospital, Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01763606
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2012 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York Presbyterian Hospital, Weill Medical College of Cornell University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patients First-ever Acute Ischemic Stroke
Keywords
Enoxaparin, Aspirin, stroke, 12-264

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin
Arm Type
Experimental
Arm Description
Patients assigned to enoxaparin.
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Patients assigned to Aspirin.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
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 Measure Information:
Title
Safety Outcomes
Description
Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death
Time Frame
1 year
Title
Feasibility Outcomes
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With or Without Recurrent Ischemic Stroke
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa DeAngelis, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan-Kettering Cancer Center

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Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

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