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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
250
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Matching placebo to be administered orally at 1 capsule, twice daily
Institut Jantung Negara
Kuala Lumpur, Malaysia
Incidence of AF
Between group incidence of post-operative AF
Time frame: 24-48 hours post-operation, up to 6-weeks after discharge
Length of hospital stay (LoHS) after surgery
1. Total Intensive/coronary care unit length of stay, 2. Total days of High Dependency Unit stay; 3. Total hospital length of stay
Time frame: Up to 2 months post-operation
Health-related quality of life (HRQoL)
Short-Form 36 Questionnaires (SF-36)
Time frame: 6-weeks after discharge
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