Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807037
• Other study ID #: T3-AF 34963
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 17, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2022
• Source: Monash University Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Dietary Supplement:
• Tocotrienols
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day

Drug:
• Placebo oral capsule
Matching placebo to be administered orally at 1 capsule, twice daily

Locations

Country	Name	City	State
Malaysia	Institut Jantung Negara	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Monash University Malaysia	Institut Jantung Negara

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AF	Between group incidence of post-operative AF	24-48 hours post-operation, up to 6-weeks after discharge
Secondary	Length of hospital stay (LoHS) after surgery	Total Intensive/coronary care unit length of stay,; Total days of High Dependency Unit stay; Total hospital length of stay	Up to 2 months post-operation
Secondary	Health-related quality of life (HRQoL)	Short-Form 36 Questionnaires (SF-36)	6-weeks after discharge