Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monash University Malaysia
• Collaborator: Institut Jantung Negara
• Treatments: Tocopherols; Tocotrienols; Tocovid; Vitamin E

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