Enoxaparin and/or Minocycline in Acute Stroke

March 29, 2016 updated by: NYU Langone Health

Pilot Study of Treatment With Intravenous Enoxaparin and/or Oral Minocycline to Limit Infarct Size After Ischemic Stroke

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital Center
      • New York, New York, United States, 10016
        • New York University Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

There are two Study Sections: A and B

--------------------------------------------

Study Section A Inclusion Criteria:

  1. acute ischemic stroke in an adult in-patient who can complete screening and begin study treatment within 6 hours of stroke onset (onset time defined as the last time the patient was known to be at his/her usual level of functioning)
  2. patient not a candidate for rTPA treatment because treatment cannot be started within the required 3 hours after stroke onset, or because rTPA treatment is refused.

Study Section A Exclusion Criteria:

  1. intracranial hemorrhage;
  2. subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
  3. history of hypersensitivity or intolerance to or toxicity from enoxaparin, other heparinoids, heparin, minocycline, or other tetracyclines;
  4. weight 125lbs or less;
  5. active bleeding;
  6. thrombolytic treatment or major surgery in the previous 24 hours;
  7. anticipated need for treatment with coumarin, or a low-molecular weight heparin other than enoxaparin, or unfractionated heparin before 36 hours after stroke onset (but see deep venous thrombosis prophylaxis, below);
  8. INR above the normal range;
  9. known coagulopathy;
  10. platelet count <100,000/mm3 (if the count drops below 100,000 while on enoxaparin, the medication will be stopped)
  11. pregnancy or lactation;
  12. undergoing dialysis; severe renal impairment (creatinine clearance known or estimated to be <30ml/min);
  13. mean arterial BP (taken to be 1/3 of the difference in mm Hg between diastolic BP and systolic BP, added to the diastolic BP) of 130 mm Hg or greater; (if the mean arterial BP is 130 mm Hg or greater but can be reduced by treatment to < 130 mm Hg, with systolic BP in the 150 169 mm Hg range, the patient may be entered).

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:

  1. acute ischemic stroke in an adult in-patient who can complete screening and begin study treatment within 24 hours of stroke onset (onset time defined as the last time the patient was known to be at his/her usual level of functioning;)
  2. patient does not qualify for, or declines to participate in, Study Section A.

Study Section B Exclusion Criteria:

  1. acute primary intracranial hemorrhage;
  2. subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
  3. pregnancy or lactation.

Patients in Study Section B will be randomly assigned to one of TWO treatment arms: minocycline, or no intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Enoxaparin
Drug: Enoxaparin
2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Other Names:
  • Lovenox®
Experimental: Minocycline
Minocycline 200 mg orally once daily for 5 days
Drug: Minocycline
200 mg orally once daily for 5 days
Other Names:
  • Minocin®
Experimental: Enoxaparin and minocycline
Drug: Enoxaparin
2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
Other Names:
  • Lovenox®
Drug: Minocycline
200 mg orally once daily for 5 days
Other Names:
  • Minocin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Within approximately 7 days of stroke onset
Within approximately 7 days of stroke onset

Secondary Outcome Measures

Outcome Measure
Time Frame
NIH Stroke Scale Scores
Time Frame: Baseline and after approximately one week
Baseline and after approximately one week
Modified Rankin Scale Score
Time Frame: Baseline, and approximately one week and 3 months later
Baseline, and approximately one week and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

James N. Kirby Foundation

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Enoxaparin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe