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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
James N. Kirby Foundation |
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00836355 |
Purpose
The purpose of this study is to investigate whether enoxaparin, minocycline, or both medications in combination may help in recovery from acute stroke.
Enoxaparin (brand name Lovenox®) is a medication approved for use in humans to prevent and to treat blood clots in deep veins in certain specific medical situations. Minocycline (brand name Minocin®) is a tetracycline antibiotic approved to treat a number of bacterial infections in humans. The investigators are studying these medications in acute human stroke because they have each been separately shown to reduce the amount of injured brain tissue in rats made to have acute ischemic stroke experimentally. In a human trial comparing minocycline with placebo (a sugar pill) acute ischemic stroke patients who took minocycline had better recovery after 1 week, 1 month and 3 months than patients who took placebo.
| Condition | Intervention |
|---|---|
|
Acute Ischemic Stroke |
Drug: Enoxaparin Drug: Minocycline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study of Treatment With Intravenous Enoxaparin and/or Oral Minocycline to Limit Infarct Size After Ischemic Stroke |
| Enrollment: | 6 |
| Study Start Date: | April 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Enoxaparin |
Drug: Enoxaparin
2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Other Name: Lovenox®
|
|
Experimental: Minocycline
Minocycline 200 mg orally once daily for 5 days
|
Drug: Minocycline
200 mg orally once daily for 5 days
Other Name: Minocin®
|
| Experimental: Enoxaparin and minocycline |
Drug: Enoxaparin
2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Other Name: Lovenox®
Drug: Minocycline
200 mg orally once daily for 5 days
Other Name: Minocin®
|
| No Intervention: Control |
Enoxaparin is a low molecular weight heparin (average molecular weight 4,500 daltons, vs. 12,000 to 15,000 daltons for unfractionated heparin) administered subcutaneously and intravenously. It is a marketed drug FDA-approved in various clinical situations for: the prevention and treatment of deep vein thrombosis; and in the treatment of acute myocardial infarction. Minocycline is an orally administered antibiotic of the tetracycline class. It is a marketed drug FDA-approved for the treatment of various bacterial and rickettsial infections. Both medications have been found to be neuroprotective in experimental stroke models. Minocycline has shown promise in a human acute stroke study.
This study is designed to investigate two logistically simple treatment regimens, singly or in combination, employing these medications for acute ischemic stroke:
The goal of treatment is neuroprotection: the limitation of the loss of brain tissue that follows ischemic stroke.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
There are two Study Sections: A and B
--------------------------------------------
Study Section A Inclusion Criteria:
Study Section A Exclusion Criteria:
Patients in Study Section A will be randomly assigned to one of the four treatment arms: enoxaparin, minocycline, enoxaparin and minocycline, or no intervention.
--------------------------------------------
Study Section B Inclusion Criteria:
Study Section B Exclusion Criteria:
Patients in Study Section B will be randomly assigned to one of TWO treatment arms: minocycline, or no intervention.
Contacts and Locations| United States, New York | |
| Bellevue Hospital Center | |
| New York, New York, United States, 10016 | |
| New York University Langone Medical Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Saran Jonas, M.D. | Department of Neurology; New York University School of Medicine |
| Study Director: | Giacinto Grieco, M.D. | Department of Neurology; New York University School of Medicine |
More Information
| Responsible Party: | Saran Jonas, M.D., Department of Neurology - NYU School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00836355 History of Changes |
| Other Study ID Numbers: | 08-131 |
| Study First Received: | February 3, 2009 |
| Last Updated: | April 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
stroke magnetic resonance imaging enoxaparin minocycline |
NIH stroke scale modified Rankin scale neuroprotection |
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
Minocycline Enoxaparin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anticoagulants Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |