Nutrition Blood Outcomes Following Tocotrienol N2B

Completed · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT01858311

Run by

Ohio State University

People needed

300

Starts

2013-03-01

Expected to finish

2018-12-01

Last updated by the study team

2021-09-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Ohio State University — Columbus, Ohio, United States
• Mount Carmel Health System — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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