Nutrition Blood Outcomes Following Tocotrienol N2B "NIIB"

Active, not recruiting

Phase N/A Results N/A

Trial Description

A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol lowering properties, both of which may benefit stroke survivors. This study is being conducted to determine the blood thinning and cholesterol lowering properties of TCT in stroke or TIA (transient ischemic attack, which is also referred to as a "mini-stroke") survivors that are receiving the standard treatment for prevention of recurrent stroke.
Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders, increases the extent of inhibition of platelet aggregation, and decreases LDL without significant side effects in stroke patients.

Detailed Description

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.

Conditions

Interventions

  • Tocotrienol Pills Dietary Supplement
    Intervention Desc: Vitamin E TCT pills - 400mg - 800mg
    ARM 1: Kind: Experimental
    Label: Tocotrienol pills (400 mg)
    Description: (2) 100mg TCT capsules following AM meal, (2) 100mg TCT capsules following PM meal.
    ARM 2: Kind: Experimental
    Label: Tocotrienol Pills 800 mg
    Description: (2) 200mg TCT capsules following AM meal, (2) 200mg TCT capsules following PM meal.
  • Placebo Vehicle Other
    Intervention Desc: Placebo capsules per day (2 in the morning and 2 in the evening)
    ARM 1: Kind: Experimental
    Label: Placebo vehicle
    Description: (2) placebo capsules following AM meal, (2) placebo capsules following PM meal.
  • Tocotrienol Capsules Dietary Supplement
    Intervention Desc: Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)
    ARM 1: Kind: Experimental
    Label: Tocotrienol capsules (400 mg)
    Description: (2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal.
    ARM 2: Kind: Experimental
    Label: Tocotrienol Capsules (800 mg)
    Description: (2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Stroke survivors within 6 months of clinical presentation for ischemic stroke or TIA event

Outcomes

Type Measure Time Frame Safety Issue
Primary platelet aggregation activity upto 1 year Yes
Secondary Decrease incidence of recurrent stroke. upto 1 year Yes
Secondary Incidence of recurrent stroke up to 1 year Yes

Biospecimen Retention:Samples With DNA - Blood Draw

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