Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

Overview

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.

Full Title of Study: “Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 19, 2021

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Mixed tocotrienols 200mg, twice daily (400mg/day)
  • Placebo Comparator: Control
    • Matching Placebo (Placebo oral capsule)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Length of hospital stay (LoHS) after surgery
    • Time Frame: Up to 2 months post-operation
    • Total Intensive/coronary care unit length of stay, Total days of High Dependency Unit stay; Total hospital length of stay
  • Health-related quality of life (HRQoL)
    • Time Frame: 6-weeks after discharge
    • Short-Form 36 Questionnaires (SF-36)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Monash University Malaysia
  • Collaborator
    • Institut Jantung Negara
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ahmad Farouk Musa, MD, Principal Investigator, Monash University Malaysia
  • Overall Contact(s)
    • Ahmad Farouk Musa, MD, +60355145630, farouk@monash.edu

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