Clinical trial NCT03807037: Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
Official title: Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation,tocotrienol,coronary artery bypass grafting
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
Collaborators: name: Institut Jantung Negara
First posted: 2019-01-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of AF
timeFrame: 24-48 hours post-operation, up to 6-weeks after discharge
Secondary outcomes:
measure: Length of hospital stay (LoHS) after surgery
timeFrame: Up to 2 months post-operation
measure: Health-related quality of life (HRQoL)
timeFrame: 6-weeks after discharge
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
Study officials:
affiliation: Monash University Malaysia
name: Ahmad Farouk Musa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Musa AF, Dillon J, Md Taib ME, Yunus AM, Sanusi AR, Nordin MN, Smith JA. A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis. J Cardiothorac Surg. 2021 Nov 24;16(1):340. doi: 10.1186/s13019-021-01721-6.