Stroke and Tocotrienol: Unique Role in Neuroprotection (SATURN)

Seberang Jaya Clinical Research Centre

Status and phase: Unknown; Phase 3

Conditions: Ischemic Stroke

Treatments: Dietary Supplement: Placebo capsules; Dietary Supplement: Tocotrienol

Study type: Interventional

Funder types: Other

Identifiers

NCT02263924

2013-CRC-001-03

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Experimental: Tocotrienol

Experimental group

Description:

Mixed tocotrienol 200mg twice a day for 6 months

Treatment:

Dietary Supplement: Tocotrienol

Placebo (for tocotrienol)

Placebo Comparator group

Description:

Placebo capsules, 1 capsule twice a day for 6 months

Treatment:

Dietary Supplement: Placebo capsules