Status:
TERMINATED
Enoxaparin and/or Minocycline in Acute Stroke
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
James N. Kirby Foundation
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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 medicatio...
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 ma...
Eligibility Criteria
Inclusion
- There are two Study Sections: A and B
- \--------------------------------------------
- Study Section A
- 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)
- 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
- intracranial hemorrhage;
- subfalcine, transtentorial, or foramen magnum herniation on CT or MRI scan of the brain;
- history of hypersensitivity or intolerance to or toxicity from enoxaparin, other heparinoids, heparin, minocycline, or other tetracyclines;
- weight 125lbs or less;
- active bleeding;
- thrombolytic treatment or major surgery in the previous 24 hours;
- 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);
- INR above the normal range;
- known coagulopathy;
- platelet count \<100,000/mm3 (if the count drops below 100,000 while on enoxaparin, the medication will be stopped)
- pregnancy or lactation;
- undergoing dialysis; severe renal impairment (creatinine clearance known or estimated to be \<30ml/min);
- 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:
- 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;)
- patient does not qualify for, or declines to participate in, Study Section A.
- Study Section B
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00836355
Start Date
April 1 2009
End Date
January 1 2010
Last Update
April 29 2016
Active Locations (2)
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1
Bellevue Hospital Center
New York, New York, United States, 10016
2
New York University Langone Medical Center
New York, New York, United States, 10016