Cancer Patients First-ever Acute Ischemic Stroke Clinical Trial
Official title:
A Pilot Trial of Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
| NCT number | NCT01763606 |
| Other study ID # | 12-264 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 18, 2012 |
| Est. completion date | April 3, 2019 |
| Verified date | April 2019 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 3, 2019 |
| Est. primary completion date | April 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center at Commack | Commack | New York |
| United States | Memorial Sloan Kettering West Harrison | Harrison | New York |
| United States | Columbia University | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | New York Presbyterian Hospital | New York | New York |
| United States | Weill Cornell Medical Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York Presbyterian Hospital, Weill Medical College of Cornell University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety Outcomes | Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death | 1 year | |
| Primary | 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. | 6 months | |
| Secondary | 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. | 6 months |