Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
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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 |
- 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.
- 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 2014 |
| Estimated Primary Completion Date: | December 2014 (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 |
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.
- Known 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| Contact: Lisa DeAngelis, MD | 212-639-7123 | |
| Contact: Babak Navi, MD | 212-639-7123 |
| 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, 10021 | |
| 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 | |
| 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: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Enoxaparin Aspirin stroke 12-264 |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Aspirin Enoxaparin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013