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Enoxaparin and/or Minocycline in Acute Stroke

2014-08-27 03:24:34 | BioPortfolio

Summary

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.

Description

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:

1. pulsed intravenous (iv) administration of enoxaparin initiated within 6 hours and completed by 24 hours after stroke onset; and

2. oral minocycline treatment once daily for five days.

The goal of treatment is neuroprotection: the limitation of the loss of brain tissue that follows ischemic stroke.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Acute Ischemic Stroke

Intervention

Enoxaparin, Minocycline

Location

Bellevue Hospital Center
New York
New York
United States
10016

Status

Enrolling by invitation

Source

New York University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:34-0400

Clinical Trials [2353 Associated Clinical Trials listed on BioPortfolio]

Neuroprotection in Acute Ischemic Stroke

This is a pilot randomized control trial (RCT) to explore the possible beneficial effect of a novel combination therapy consisting of molecular hydrogen H2 plus minocycline ("H2M"), on neu...

PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)

Primary objective: - To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 d...

Neuroprotection With Minocycline Therapy for Acute Stroke Recovery Trial

Background: Stroke is a leading cause of death and chronic serious disability worldwide. Minocycline, a semisynthetic tetracycline, has consistently been shown in recent years to be neuro...

Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 within 1-9 hours of acute ischemic stroke onset, and then for 3 additional da...

Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke

The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on admission might be predictive for early neurological deterioration in acute ischemic stroke patient...

PubMed Articles [7799 Associated PubMed Articles listed on BioPortfolio]

Blood Pressure Goals in Acute Stroke-How Low Do You Go?

Elevations in systolic blood pressure (BP) greater than 140 mmHg are reported in the majority (75%) of patients with acute ischemic stroke and in 80% of patients with acute intracerebral hemorrhages ...

Circulating Troponin I Level in Patients with Acute Ischemic Stroke.

Cardiac troponin levels in the blood are an important biomarker of acute coronary events, but may also be elevated in the context of acute ischemic stroke without an obvious concurrent myocardial insu...

An international cluster-randomized quality improvement trial to increase the adherence to evidence-based therapies for acute ischemic stroke and transient ischemic attack patients: Rationale and design of the BRIDGE STROKE Trial.

Translating evidence into clinical practice in the management of acute ischemic stroke (AIS) and transient ischemic attack (TIA) is challenging especially in low- and middle-income countries.

Homocysteine is Associated with Exaggerated Morning Blood Pressure Surge in Patients with Acute Ischemic Stroke.

Considerable researches suggest that high level of homocysteine (Hcy) is associated with the risk of ischemic stroke. Ambulatory blood pressure monitoring (ABPM) parameters have also been confirmed as...

Renal dysfunction increases the risk of recurrent stroke in patients with acute ischemic stroke.

This study investigated risks of short-term (1 and 3 months) and long-term (1-year) recurrent stroke associated with glomerular filtration rate (eGFR) in patients with acute ischemic stroke.

Medical and Biotech [MESH] Definitions

The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.

A drug combination of aspirin and dipyridamole that functions as a PLATELET AGGREGATION INHIBITOR, used to prevent THROMBOSIS and STROKE in TRANSIENT ISCHEMIC ATTACK patients.

Ischemic injury to the OPTIC NERVE which usually affects the OPTIC DISK (optic neuropathy, anterior ischemic) and less frequently the retrobulbar portion of the nerve (optic neuropathy, posterior ischemic). The injury results from occlusion of arterial blood supply which may result from TEMPORAL ARTERITIS; ATHEROSCLEROSIS; COLLAGEN DISEASES; EMBOLISM; DIABETES MELLITUS; and other conditions. The disease primarily occurs in the sixth decade or later and presents with the sudden onset of painless and usually severe monocular visual loss. Anterior ischemic optic neuropathy also features optic disk edema with microhemorrhages. The optic disk appears normal in posterior ischemic optic neuropathy. (Glaser, Neuro-Ophthalmology, 2nd ed, p135)

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

Sudden death from overwork, most often as a result of acute CARDIOVASCULAR STROKE.

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