Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

August 23, 2022 updated by: Monash University Malaysia

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Mixed tocotrienols 200mg, twice daily (400mg/day)
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Other Names:
  • Tocovid Suprabio
Placebo Comparator: Control
Matching Placebo (Placebo oral capsule)
Matching placebo to be administered orally at 1 capsule, twice daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay (LoHS) after surgery
Time Frame: 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
Up to 2 months post-operation
Health-related quality of life (HRQoL)
Time Frame: 6-weeks after discharge
Short-Form 36 Questionnaires (SF-36)
6-weeks after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ahmad Farouk Musa, MD, Monash University Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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