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Acute Ischemic StrokeNCT00836355

Enoxaparin and/or Minocycline in Acute Stroke

A study testing Enoxaparin and Minocycline in people with Acute Ischemic Stroke, run by NYU Langone Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Enoxaparin and Minocycline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
Apr 2009to Jan 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Bellevue Hospital Center

    New York, New York, 10016

  • New York University Langone Medical Center

    New York, New York, 10016

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Enoxaparin, Minocycline
Keywords
stroke, magnetic resonance imaging, enoxaparin, minocycline, NIH stroke scale, modified Rankin scale, neuroprotection
Medical subject headings
Ischemic Stroke, Stroke, cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoxaparinDrug

    Also called Lovenox®

    2 (or 3) intravenous doses, the first on study entry, the last 24 hours later

  • MinocyclineDrug

    Also called Minocin®

    200 mg orally once daily for 5 days

Study groups in NCT00836355
Study groupRoleWhat they receive
EnoxaparinExperimentalNot described
Receives: Drug: Enoxaparin
MinocyclineExperimentalMinocycline 200 mg orally once daily for 5 days
Receives: Drug: Minocycline
Enoxaparin and minocyclineExperimentalNot described
Receives: Drug: Enoxaparin; Drug: Minocycline
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within approximately 7 days of stroke onset

Secondary outcomes (2)

  1. NIH Stroke Scale Scores

    Measured: Baseline and after approximately one week

  2. Modified Rankin Scale Score

    Measured: Baseline, and approximately one week and 3 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2009
  4. Study completionJan 2010

Why it stopped: Too few acute stroke patients available to meet enrollment requirements.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00836355
Sponsor's protocol ID
08-131
Status last verified
Mar 2016
First submitted
3 Feb 2009
Last updated
29 Apr 2016
Data monitoring committee
No

Publications

  • Lampl Y, Boaz M, Gilad R, Lorberboym M, Dabby R, Rapoport A, Anca-Hershkowitz M, Sadeh M. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study. Neurology. 2007 Oct 2;69(14):1404-10. doi: 10.1212/01.wnl.0000277487.04281.db.

    PubMed 17909152

  • Mary V, Wahl F, Uzan A, Stutzmann JM. Enoxaparin in experimental stroke: neuroprotection and therapeutic window of opportunity. Stroke. 2001 Apr;32(4):993-9. doi: 10.1161/01.str.32.4.993.

    PubMed 11283402

  • Quartermain D, Li Y, Jonas S. Enoxaparin, a low molecular weight heparin decreases infarct size and improves sensorimotor function in a rat model of focal cerebral ischemia. Neurosci Lett. 2000 Jul 14;288(2):155-8. doi: 10.1016/s0304-3940(00)01223-4.

    PubMed 10876084

  • Quartermain D, Li YS, Jonas S. The low molecular weight heparin enoxaparin reduces infarct size in a rat model of temporary focal ischemia. Cerebrovasc Dis. 2003;16(4):346-55. doi: 10.1159/000072556.

    PubMed 13130175

  • Xu L, Fagan SC, Waller JL, Edwards D, Borlongan CV, Zheng J, Hill WD, Feuerstein G, Hess DC. Low dose intravenous minocycline is neuroprotective after middle cerebral artery occlusion-reperfusion in rats. BMC Neurol. 2004 Apr 26;4:7. doi: 10.1186/1471-2377-4-7.

    PubMed 15109399

  • Yrjanheikki J, Tikka T, Keinanen R, Goldsteins G, Chan PH, Koistinaho J. A tetracycline derivative, minocycline, reduces inflammation and protects against focal cerebral ischemia with a wide therapeutic window. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13496-500. doi: 10.1073/pnas.96.23.13496.

    PubMed 10557349

  • Liu Z, Fan Y, Won SJ, Neumann M, Hu D, Zhou L, Weinstein PR, Liu J. Chronic treatment with minocycline preserves adult new neurons and reduces functional impairment after focal cerebral ischemia. Stroke. 2007 Jan;38(1):146-52. doi: 10.1161/01.STR.0000251791.64910.cd. Epub 2006 Nov 22.

    PubMed 17122429

Questions about this trial

What is this clinical trial studying?

A study testing Enoxaparin and Minocycline in people with Acute Ischemic Stroke, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00836355, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.

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