Enoxaparin and/or Minocycline in Acute Stroke

Terminated

Phase N/A Results

Trial Description

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.

Detailed 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.

Trial Stopped: Too few acute stroke patients available to meet enrollment requirements.

Conditions

Interventions

  • Enoxaparin (Lovenox®)Drug
    Intervention Desc: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
    ARM 1: Kind: Experimental
    Label: Enoxaparin
    ARM 2: Kind: Experimental
    Label: Enoxaparin and minocycline
  • Minocycline (Minocycline hydrochloride)Drug
    Other Names: Minocin; Minomycin; Akamin
    Intervention Desc: 200 mg orally once daily for 5 days
    ARM 1: Kind: Experimental
    Label: Minocycline
    Description: Minocycline 200 mg orally once daily for 5 days
    ARM 2: Kind: Experimental
    Label: Enoxaparin and minocycline

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Indices of salvaged ischemic penumbra and of final infarct volume based on quantitative volumetric analyses of pre- and post-treatment perfusion-weighted and diffusion-weighted brain MR imaging Within approximately 7 days of stroke onset Yes
Secondary NIH Stroke Scale scores Baseline and after approximately one week No
Secondary Modified Rankin Scale score Baseline, and approximately one week and 3 months later No

Sponsors