Atrial Fibrillation
Conditions
Keywords
atrial fibrillation,tocotrienol,coronary artery bypass grafting
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTTocotrienols
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
DRUGPlacebo oral capsule
Matching placebo to be administered orally at 1 capsule, twice daily
Sponsors
Institut Jantung Negara
Monash University Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females 2. More than 18 years of age 3. Elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery
Exclusion criteria
1. Less than 18 years of age 2. Refusal to have surgery 3. Urgent or emergency surgery 4. Off-pump surgery 5. Poor LV (EF \< 30%) 6. Inability to give informed consent 7. Documented allergy to palm oil or Vitamin E 8. Documented AF or any form of arrhythmia pre-operatively 9. Currently on or indicated for long-term corticosteroid treatment 10. Patients who have been included in any other clinical trial within the previous three months 11. Patients who are on supplementation of Vitamin E or other potent anti-oxidants up to 1 month before randomisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AF | 24-48 hours post-operation, up to 6-weeks after discharge | Between group incidence of post-operative AF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (LoHS) after surgery | Up to 2 months post-operation | 1. Total Intensive/coronary care unit length of stay, 2. Total days of High Dependency Unit stay; 3. Total hospital length of stay |
| Health-related quality of life (HRQoL) | 6-weeks after discharge | Short-Form 36 Questionnaires (SF-36) |
Countries
Malaysia
Outcome results
None listed