NCT03807037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2 atrial-fibrillation

Timeline
Completed

Started Dec 2018

Typical duration for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

January 14, 2019

Last Update Submit

August 23, 2022

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation,tocotrienol,coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • Incidence of AF

    Between group incidence of post-operative AF

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

Secondary Outcomes (2)

  • Length of hospital stay (LoHS) after surgery

    Up to 2 months post-operation

  • Health-related quality of life (HRQoL)

    6-weeks after discharge

Study Arms (2)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Tocotrienols

Control

PLACEBO COMPARATOR

Matching Placebo (Placebo oral capsule)

Drug: Placebo oral capsule

Interventions

TocotrienolsDIETARY_SUPPLEMENT

Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day

Also known as: Tocovid Suprabio
Treatment
Placebo oral capsuleDRUG

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Related Publications (2)

  • Musa AF, Dillon J, Taib MEM, Yunus AM, Sanusi AR, Nordin MN, Smith JA. Incidence and Outcomes of Postoperative Atrial Fibrillation after Coronary Artery Bypass Grafting of a Randomized Controlled Trial: A Blinded End-of-cycle Analysis. Rev Cardiovasc Med. 2022 Apr 1;23(4):122. doi: 10.31083/j.rcm2304122. eCollection 2022 Apr.

    PMID: 39076222DERIVED

  • Musa AF, Dillon J, Md Taib ME, Yunus AM, Sanusi AR, Nordin MN, Smith JA. A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis. J Cardiothorac Surg. 2021 Nov 24;16(1):340. doi: 10.1186/s13019-021-01721-6.

    PMID: 34819126DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Tocotrienols

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmad Farouk Musa, MD

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

December 17, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)