Nutrition Blood Outcomes Following Tocotrienol N2B

In this Phase IIB trial the goal is to determine the effects of orally supplemented TCT on
platelet function and cholesterol as well as the safety in patients with TIA (transient
ischemic attack) or stroke in addition to the standard treatment for stroke prevention.
Recurrent cardiovascular events including stroke, TIA, heart attack, venous thrombosis,
pulmonary embolism, systemic embolism will also be recorded. In patients with recurrent
stroke, severity of the stroke and stroke size measured from MR (magnetic resonance) or CT
(computed tomography) imaging will also be collected. We expect that TCT will inhibit blood
clotting and lower cholesterol more than current standard treatment without significantly
increasing bleeding risks or other side effects. Future work is planned in a larger
TIA/stroke population to examine whether TCT adds to standard medical care in terms of
decreasing incidence of stroke and improving outcomes following stroke.

Inclusion Criteria:

- Patients with either atherothrombotic, cardioembolic, cryptogenic stroke or TIA
(transient ischemic attack) for whom anticoagulation is not indicated

- Enrollment in trial must occur within 6 months of clinical presentation for first
stroke or TIA event

- No history of long-term vitamin E supplement (defined as daily oral tocopherol or
tocotrienol supplementation at least 6mos; within the past 5 years)

- No current vitamin E supplementation in multi-vitamin

Exclusion Criteria:

- Disabling stroke ( Modified Rankin Scale > 3)

- Prior intracranial hemorrhage (excluding traumatic)

- High risk of bleeding (recurrent gastrointestinal, genitourinary bleeding, active
peptic ulcer disease)

- Anticipated requirement for long term use of anticoagulation

- Contraindications to antiplatelet agents (bleeding disorder, thrombocytopenia,
prolonged INR)

- Irreversible medical condition likely to affect short-term survival or ability to
participate in study such as cancer or other chronic disease with predicted survival
of less than a year or severe psychiatric or neurologic disease that might complicate
evaluation of study outcomes like dementia or schizophrenia

- Pregnancy or women of child bearing age who are not following an effective method of
contraception

- Breast feeding

- Unable or unwilling to provide informed

- Unlikely to be compliant with therapy or unwilling to return for follow up frequent
clinic visits

- Concurrent participation in another study with an investigational drug or devise

- Other likely specific cause of stroke such as dissection, infectious or noninfectious
vasculitis, prothrombotic state