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Completed

NCT Number: NCT03807037

Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females
  • More than 18 years of age
  • Elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery

Exclusion criteria

  • Less than 18 years of age
  • Refusal to have surgery
  • Urgent or emergency surgery
  • Off-pump surgery
  • Poor LV (EF < 30%)
  • Inability to give informed consent
  • Documented allergy to palm oil or Vitamin E
  • Documented AF or any form of arrhythmia pre-operatively
  • Currently on or indicated for long-term corticosteroid treatment
  • Patients who have been included in any other clinical trial within the previous three months
  • Patients who are on supplementation of Vitamin E or other potent anti-oxidants up to 1 month before randomisation

Treatment and study plan

Tocotrienols

Dietary Supplement

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 oral capsule

Drug

Matching placebo to be administered orally at 1 capsule, twice daily

Primary outcomes

  1. Incidence of AF

    Time frame: 24-48 hours post-operation, up to 6-weeks after discharge

    Between group incidence of post-operative AF

Secondary outcomes

  1. 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
  2. Health-related quality of life (HRQoL)

    Time frame: 6-weeks after discharge

    Short-Form 36 Questionnaires (SF-36)

Sponsors and collaborators

Lead sponsor

Monash University Malaysia

Other

Collaborators

  • Institut Jantung Negara

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 16, 2019
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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