Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Dietary Supplement: Tocotrienols; Drug: Placebo oral capsule

• Registration Number: NCT03807037
• Lead Sponsor: Monash University Malaysia

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.

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Tocotrienols	Mixed tocotrienols 200mg, twice daily (400mg/day)
Control	Placebo oral capsule	Matching Placebo (Placebo oral capsule)

Primary Outcome Measures

Name	Time	Method
Incidence of AF	24-48 hours post-operation, up to 6-weeks after discharge	Between group incidence of post-operative AF

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Institut Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia