Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01763606
First received: December 20, 2012
Last updated: June 18, 2014
Last verified: June 2014

December 20, 2012
June 18, 2014
December 2012
December 2015   (final data collection date for primary outcome measure)
  • 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.
Safety Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The clinical visit will consist of history taking and physical examination, and will assess for adherence to study drug (using the 8-point Morisky medication adherence scale) and any symptoms or signs of clinical thromboembolism, bleeding episodes, or serious adverse events. Adverse events will be graded using version 4.0 of the NCI Common Terminology Criteria for Adverse Events.
Complete list of historical versions of study NCT01763606 on ClinicalTrials.gov Archive Site
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.
Efficacy Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The study investigator will also assess functional outcomes by performing a modified Rankin Scale (mRS), a National Institute of Health Stroke Scale NIHSS), and a Karnofsky Performance Status Scale (KPSS).
Not Provided
Not Provided
 
Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer Patients First-ever Acute Ischemic Stroke
  • 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.
  • 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).
  • Experimental: Enoxaparin
    Patients assigned to enoxaparin.
    Intervention: Drug: Enoxaparin
  • Experimental: Aspirin
    Patients assigned to Aspirin.
    Intervention: Drug: Aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2015   (final data collection date for primary outcome measure)

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 centers 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.
Both
18 Years to 85 Years
No
Contact: Lisa DeAngelis, MD 212-639-7123
Contact: Babak Navi, MD 212-639-7123
United States
 
NCT01763606
12-264
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Principal Investigator: Lisa DeAngelis, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP