ACUTE INFARCTION TRIALS:
     Within 3.5 hours of onset:
         SAINT II– Acute Ischemic Stroke Study

     Within 24 hours of onset:
           TAISHO PHASE I   ISCHEMIC STROKE STUDY 

 ACUTE INTRACEREBRAL HEMORRAGE TRIALS:
      Within 3 hours of onset:
           NOVO 7 PHASE III, DOSE-ESCALATION STUDY

 
Non-Emergent Stroke Trials

  SWISS STUDY -  SIBLINGS WITH ISCHEMIC STROKE
       Objective: To test the hypothesis that there exist human chromosomal regions of interest                                     associated with ischemic stroke.
 
  The PRoFESS STROKE STUDY 
        A STROKE SECONDARY PREVENTION STUDY OF AGGRENOX® VS. CLOPIDOGREL, WITH                      AND WITHOUT MICARDIS®

  INSULIN RESISTANCE INTERVENTION AFTER STROKE (IRIS) TRIAL
        A SECONDARY STROKE PREVENTION STUDY USING PIOGLITAZONE (ACTOS®),                                  COMPARED WITH PLACEBO

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ACUTE INFARCTION TRIALS:

WITHIN 3.5 HOURS OF ONSET:

Title: SAINT II– Acute Ischemic Stroke Study,
          NXY059 PHASE IIB/III ISCHEMIC STROKE STUDY 

Objective: Demonstrate the efficacy of NXY-059 as a possible neuroprotective agent compared to placebo in subjects with acute ischemic stroke

Inclusion Criteria:

      1.  Within 3.5 hours of symptom onset, administration of tPA allowable, study drug
           must be initiated prior to, during, or within 30 minutes of completion of tPA
      2.  Minimum NIH Stroke scale of 6 with associated motor weakness (Arm & Motor section >2)

Exclusion Criteria:

1. Use of thrombolytic agents (except tPA), nimodipine, pentoxifylline, citicoline, acetazolamide* and methotrexate* (*during the 72-hour infusion)
2. Use of any investigational drug or procedure

Contact liaison:  Attending Neurologist or Stroke Fellow

WITHIN 24 HOURS OF ONSET:

Title: TAISHO PHASE I   ISCHEMIC STROKE STUDY 

 Objective:  TS-011 is vasoconstrictor in the cerebral circulation and regulates vascular tone and autoregulation of cerebral blood flow.  Data from non-clinical studies show IV administration of TS-011 reduces the increased infarct volume significantly.  This study will demonstrate the safety of ascending doses TS-011 compared to placebo in subjects with acute ischemic stroke.

Inclusion Criteria: 

        1.  Within 24 hours of symptom onset
        2.  Ages 18 to 85 years
        3.  NIH stroke scale must be between 4 and 22 within an hour of dosing

Exclusion Criteria:

        1.  May not have received TPA during management for this patient’s present stroke                symptoms
        2.  Moderate to severe nausea, vomitting or myoclonus-like involuntary movements are also
               exclusions

Contact liaison:  Attending Neurologist or Stroke Fellow

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ACUTE INTRACEREBRAL HEMORRAGE TRIALS:

Within 3 hours of onset:

Title: NOVO 7 PHASE III, DOSE-ESCALATION STUDY

Objective: Evaluate the safety of rFVIIa (Novo-Seven®) in reducing disability and improving clinical outcome by preventing early hematoma growth in acute ICH

Inclusion Criteria: Patient meets the following criteria:

• Age > 18 years
• Spontaneous intracerebral hemorrhage (ICH) diagnosed by CT scan within 3 hours of symptom onset
• CT head to Novoseven® administration within 1 hour only

Exclusion Criteria: Patient DOES NOT HAVE any of the following:

• Time of symptom onset of ICH is unknown or more than 3 hours
• Patients with secondary ICH related to infarction, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM), thrombolysis, or severe trauma
• Surgical hematoma evacuation planned within 24 hours of symptom onset
• Deep coma (GCS 3-5) at the time of admission
• INR is > 1.4; aspirin or plavix use is not an exclusion criterion
• Platelets < 50,000/mL
• Any history of hemophilia or other coagulopathy
• Thrombotic or vaso-occlusive disease (i.e., angina, claudication, deep-vein thrombosis, or cerebral or myocardial infarction/ischemia)
• Pregnancy

Contact liaison:  Attending Neurologist or Stroke Fellow

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Non-Emergent Stroke Trials

SWISS STUDY -  SIBLINGS WITH ISCHEMIC STROKE

Objective: To test the hypothesis that there exist human chromosomal regions of interest associated with ischemic stroke.  This hypothesis will be tested by performing a genome-wide screen using DNA samples collected in this study from 300 concordant sibling pairs.  2) To establish a secured cell bank of specimens from these sibpairs.

Inclusion Criteria:

      1. Subjects must have had an ischemic stroke
      2. Subject must be part of a concordant sibling pair

Exclusion Criteria: None

Contact liaison: Attending Neurologist or Stroke Fellow

Procedure: Relevant information will be collected by research team

The PRoFESS STROKE STUDY

A STROKE SECONDARY PREVENTION STUDY OF AGGRENOX® VS. CLOPIDOGREL, WITH AND WITHOUT MICARDIS® 

Objectives: To investigate which of four treatment regimens utilizing commonly prescribed
medications is best in preventing recurrent stroke in patients who have already suffered an ischemic stroke. This study will include over 15,500 patients in at least 24 countries and last approximately four years.

Inclusion Criteria: Subjects must have had an ischemic stroke

Exclusion Criteria:

        1.  Subjects may not have previously used Aggrenox®, clopidogrel®, or Micardis®
        2.  Planned anticoagulation and antithrombotic usage

Contact liaison: Attending Neurologist or Stroke Fellow

INSULIN RESISTANCE INTERVENTION AFTER STROKE (IRIS) TRIAL

A SECONDARY STROKE PREVENTION STUDY USING PIOGLITAZONE (ACTOS®), COMPARED
WITH PLACEBO

Objectives: IRIS will test the effectiveness of pioglitazone (Actos®), compared with placebo, for prevention of recurrent stroke and myocardial infarction among non-diabetic men and women with a recent ischemic stroke and insulin resistance.   IRIS is one of the largest trials ever funded by the National Institutes of Neurological Disorders and Stroke.

Mechanism of Action: The study drug, pioglitazone, is an insulin sensitizing agent that is
currently used to treat diabetes.  In pre-clinical and clinical research it has been shown to
reduce vascular inflammation, favorably alter blood lipids, and reduce the progression
of atherosclerosis.  The IRIS is based on the hypothesis that reducing insulin resistance with
pioglitazone will prevent recurrent vascular events among persons with ischemic stroke.

Inclusion Criteria:

      1.  Subjects must have had an ischemic stroke
      2.  Subjects must be at least 45 years of age

Exclusion Criteria:

1. Subjects may not have previously used pioglitazone
2. Subjects must not have had a diagnosis of diabetes at any previous time

Contact liaison: Attending Neurologist or Stroke Fellow