Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

Study Overview
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Brief Summary
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This study is a prospective, randomized, controlled trial with parallel groups to assess the effects of tocotrienol in the occurrence of atrial fibrillation (AF) post-CABG.

Detailed Description
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At present, guidelines exist in Europe and the USA on the pharmacological prophylaxis and management of postoperative AF. However, these are subject to a number of limitations including treatment failure, toxicity and pro-arrhythmogenicity. Hence, efforts have been made to develop alternative preventive strategies. The understanding of the role of oxidative stress as a mechanism for AF development has made way for antioxidant vitamins as novel therapeutic and preventive agents. In view of emerging evidence on the HMG-CoA reductase inhibitory role in the incidence of AF and established inhibitory properties of tocotrienols, we postulate that supplementation with tocotrienols may exert therapeutic advantage in the safety endpoints of post-CABG. The modulation of oxidative stress status and anti-inflammatory via HMG-CoA reductase inhibition may work synergistically in affecting the incidence of AF post-CABG.

Official Title
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Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Dietary Supplement: Tocotrienols
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females More than 18 years of age Elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery Exclusion Criteria: Less than 18 years of age Refusal to have surgery Urgent or emergency surgery Off-pump surgery Poor LV (EF < 30%) Inability to give informed consent Documented allergy to palm oil or Vitamin E Documented AF or any form of arrhythmia pre-operatively Currently on or indicated for long-term corticosteroid treatment Patients who have been included in any other clinical trial within the previous three months Patients who are on supplementation of Vitamin E or other potent anti-oxidants up to 1 month before randomisation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Mixed tocotrienols 200mg, twice daily (400mg/day) | Dietary Supplement: Tocotrienols<br>* Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day<br>* Other names: Tocovid Suprabio;|
| Placebo Comparator: Control<br>Matching Placebo (Placebo oral capsule) | Drug: Placebo oral capsule<br>* Matching placebo to be administered orally at 1 capsule, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AF | Between group incidence of post-operative AF | 24-48 hours post-operation, up to 6-weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (LoHS) after surgery | Total Intensive/coronary care unit length of stay, Total days of High Dependency Unit stay; Total hospital length of stay | Up to 2 months post-operation | 
| Health-related quality of life (HRQoL) | Short-Form 36 Questionnaires (SF-36) | 6-weeks after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation,tocotrienol,coronary artery bypass grafting