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| Name | Class |
|---|---|
| Malaysia Palm Oil Board | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo vehicle | (2) placebo capsules following AM meal and (2) placebo capsules following PM meal. |
| |
| Tocotrienol capsules (400 mg) | (2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal. |
| |
| Tocotrienol Capsules (800 mg) | (2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol Capsules | Dietary Supplement | Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| platelet aggregation activity | Platelet aggregation activity will be measured using standard clinical laboratory procedures | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of recurrent stroke | Incidence of recurrent stroke after previous diagnosed stroke or TIA. | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Stroke survivors within 6 months of clinical presentation for ischemic stroke or TIA event
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States | ||
| Mount Carmel Health System |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Blood Draw
| Placebo Vehicle | Other | Placebo capsules per day (2 in the morning and 2 in the evening) |
|
| Columbus |
| Ohio |
| 43213 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |