Stroke and Tocotrienol: Unique Role in Neuroprotection "SATURN"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Age 35 years old and above
- Subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischemic stroke with NIHSS 6-20
- Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions.
- Subject has a Modified Rankin Scale from 2-4
- Subject has a clinical stroke diagnosis according to WHO stroke diagnosis
- Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist
- Subject or his/her legally accepted representatives is willing to provide written informed consent

Exclusion Criteria

- Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
- Severe stroke as assessed clinically and/or by appropriate imaging techniques
- Subject has other significant non-ischemic brain lesion(s) which could affect function or disability
- Time of ischemic stroke onset not exactly known
- Subject has co-existing systemic disease which may affect assessment or follow-up such as terminal cancer, renal failure (serum creatinine >200umol/L if known), liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis
- Subject with significant liver impairment (liver function tests of five time the upper limit level)
- Subject has definite indications for full dose or long-term anti-coagulation therapy (such as warfarin)
- Any condition that in the judgement of the investigator would place the patient under undue risks
- Traumatic brain injury within the previous 30days
- Symptoms which are rapidly improving (as in transient ischemic stroke)
- Patient with recurrent stroke
- The patient is female with child-bearing potential (unless the subjects are on contraception measurement) or breast feeding
- Patients who have been included in any other clinical trials within the previous three months