Enoxaparin Versus Aspirin in Patients With Cancer and Stroke

NCT01763606 | Completed Results

• 1 other identifier: 12-264
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

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

Keywords

Enoxaparin; Aspirin; stroke; 12-264

Outcome Measures

Primary Outcomes (2)

• Safety Outcomes

  Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death

  1 year

• 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 Outcomes (1)

• Number of Participants With or Without Recurrent Ischemic Stroke

  6 months

Study Arms (2)

Enoxaparin

EXPERIMENTAL

Patients assigned to enoxaparin.

Drug: Enoxaparin

Aspirin

EXPERIMENTAL

Patients assigned to Aspirin.

Drug: Aspirin

Interventions

Enoxaparin 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.

Enoxaparin

Aspirin 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).

Aspirin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• New York Presbyterian Hospital: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Columbia University

New York, New York, United States

Location

Weill Cornell Medical Center

New York, New York, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Stroke

Interventions

Enoxaparin; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Lisa DeAngelis, MD
• Organization: Memorial Sloan Kettering Cancer Center

deangell@mskcc.org

212-639-8000

Study Officials

• Lisa DeAngelis, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 9, 2013
• Study Start: December 18, 2012
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: August 14, 2020
• Results First Posted: May 15, 2020

Record last verified: 2019-04

Locations

US (7)