Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

NCT ID: NCT01763606

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-18
• Study Completion Date: 2019-04-03

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.

Conditions

Cancer Patients First-ever Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enoxaparin

Patients assigned to enoxaparin.

Group Type: EXPERIMENTAL

Enoxaparin

Intervention Type: DRUG

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.

Aspirin

Patients assigned to Aspirin.

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa DeAngelis, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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

Memorial Sloan Kettering Cancer Center

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Columbia University

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan-Kettering Cancer Center

Other Identifiers

12-264

Identifier Type: -

Identifier Source: org_study_id