Ischemic Stroke
Conditions
Brief summary
Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in patients with moderate ischemic stroke. 150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol 200mg twice a day for 6 months. Patients will be followed up and assessed on their functional recovery.
Interventions
DIETARY_SUPPLEMENTTocotrienol
Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
DIETARY_SUPPLEMENTPlacebo capsules
Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
Sponsors
Clinical Research Centre Hospital Taiping
Universiti Sains Malaysia
Seberang Jaya Clinical Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20) Inclusion Criteria: 1. Age 35 years old and above. 2. Subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischaemic stroke with NIHSS between 6 - 20. 3. Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions. 4. Subject has a modified Rankin Scale from 2-4. 5. Subject has a clinical stroke diagnosis according to WHO stroke diagnosis. 6. Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist 7. Subjects or his/her legally acceptable representative is willing to provide written informed consent.
Exclusion criteria
1. Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI 2. Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event. 3. Severe stroke as assessed clinically and/or by appropriate imaging techniques 4. Subject has other significant non-ischemic brain lesion(s) which could affect function or disability. 5. Time of ischemic stroke onset not exactly known 6. Subject has documented underlying medical conditions which may affect assessment or follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart disease, severe liver disease or renal failure (based on recent medical history) 7. Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia 8. Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin) 9. Any condition that in the judgment of the investigator would place the patient under undue risk 10. Traumatic brain injury within the previous 30 days. 11. Symptoms which are rapidly improving (as in transient ischemic stroke) 12. The patient is pregnant, breast feeding or female of childbearing potential (unless the subject is willing to practice on double contraception measures for the study duration) until up to 1 month (30 days) after last treatment dose. 13. Patients who have been included in any other clinical trial within the previous three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Score | 6th Month | Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Score | 3rd month | Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio) |
| Modified Barthel Index | 6th months | • Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment) |
| NIHSS | before dosing and at 6th month | Reduction in NIHSS at the end of 6 months of treatment from baseline |
| Composite score (MRS, NIHSS, mBI) | 6th month | Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS \<6, and mBI at least 95 |
| MRI - Brain lesion volume | 6th month | Change in stroke lesion volume |
| SF-36 | 6th month | quality of life |
| CLOX and TMT Parts A & B | 6th month | Improvement in the score of CLOX and TMT Parts A & B at the end of 24-weeks of treatment from baseline |
| Adverse event monitoring | 6 months | Adverse event outcomes in both groups |
Countries
Malaysia
Contacts
Primary ContactIRENE LOOI
Backup ContactWEN YAO MAK
Outcome results
None listed