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Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation

Sponsor
Monash University Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT03807037
Collaborator
Institut Jantung Negara (Other)
250
Enrollment
1
Location
2
Arms
36.4
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Tocotrienols
  • Drug: Placebo oral capsule
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial
Actual Study Start Date :
Dec 17, 2018
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Mixed tocotrienols 200mg, twice daily (400mg/day)

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
Other Names:
  • Tocovid Suprabio

    		•
    Placebo Comparator: Control

    Matching Placebo (Placebo oral capsule)

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of AF [24-48 hours post-operation, up to 6-weeks after discharge]

      Between group incidence of post-operative AF

    Secondary Outcome Measures

    1. Length of hospital stay (LoHS) after surgery [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) [6-weeks after discharge]

      Short-Form 36 Questionnaires (SF-36)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Jantung Negara Kuala Lumpur Malaysia 50400

    Sponsors and Collaborators

    • Monash University Malaysia
    • Institut Jantung Negara

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Monash University Malaysia
    ClinicalTrials.gov Identifier:
    NCT03807037
    Other Study ID Numbers:
    • T3-AF 34963
    First Posted:
    Jan 16, 2019
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Monash University Malaysia
    atrial fibrillation,tocotrienol,coronary artery bypass grafting
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Tocotrienols
    Vitamin E
    Tocopherols
    Tocovid

    Study Results

    No Results Posted as of Aug 25, 2022