Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of AF
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females
- •More than 18 years of age
- •Elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery
排除标准
- •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
研究组 & 干预措施
Control
Matching Placebo (Placebo oral capsule)
干预措施: Placebo oral capsule (Drug)
Treatment
Mixed tocotrienols 200mg, twice daily (400mg/day)
干预措施: Tocotrienols (Dietary Supplement)
结局指标
主要结局
Incidence of AF
时间窗: 24-48 hours post-operation, up to 6-weeks after discharge
Between group incidence of post-operative AF
次要结局
- Length of hospital stay (LoHS) after surgery(Up to 2 months post-operation)
- Health-related quality of life (HRQoL)(6-weeks after discharge)