Institut Jantung Negara
Kuala Lumpur, 50400, Malaysia
NCT Number: NCT03807037
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Kuala Lumpur, 50400, Malaysia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Other names: Tocovid Suprabio
Matching placebo to be administered orally at 1 capsule, twice daily
Time frame: 24-48 hours post-operation, up to 6-weeks after discharge
Between group incidence of post-operative AF
Time frame: Up to 2 months post-operation
Time frame: 6-weeks after discharge
Short-Form 36 Questionnaires (SF-36)
Monash University Malaysia
Other
Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial
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