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Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01763606
First received: December 20, 2012
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Cancer Patients First-ever Acute Ischemic Stroke
Drug: Enoxaparin
Drug: Aspirin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Safety Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The primary safety outcomes will consist of intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death.

  • Feasibility Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. Additional feasibility outcomes include patient dropout or crossover among randomized patients and adherence to study drug.


Secondary Outcome Measures:
  • Efficacy Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enoxaparin
Patients assigned to enoxaparin.
Drug: Enoxaparin
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.
Experimental: Aspirin
Patients assigned to Aspirin.
Drug: Aspirin
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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763606

Contacts
Contact: Lisa DeAngelis, MD 212-639-7123
Contact: Babak Navi, MD 212-639-7123

Locations
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Lisa DeAngelis, MD    212-639-7123      
Contact: Babak Navi, MD    212-639-7123      
United States, New York
Memorial Sloan Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Lisa DeAngelis, MD    212-639-7123      
Contact: Babak Navi, MD    212-639-7123      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lisa DeAngelis, M.D.    212-639-7123      
Contact: Babak Navi, MD    212-639-7123      
Principal Investigator: Lisa DeAngelis, M.D.         
Sub-Investigator: Babak Navi, MD         
New York Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10065
Contact: Randolph Marshall, MD         
Principal Investigator: Randolph Marshall, MD         
Weill Cornell Medical Center Not yet recruiting
New York, New York, United States
Contact: Babak Navi, MD    212-639-7123      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Weill Medical College of Cornell University
Investigators
Principal Investigator: Lisa DeAngelis, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01763606     History of Changes
Other Study ID Numbers: 12-264
Study First Received: December 20, 2012
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Enoxaparin
Aspirin
stroke
12-264

Additional relevant MeSH terms:
Aspirin
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents

ClinicalTrials.gov processed this record on November 24, 2014