Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Tocotrienols
Placebo oral capsule
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation,tocotrienol,coronary artery bypass grafting
Eligibility Criteria
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
Sites / Locations
- Institut Jantung Negara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
Mixed tocotrienols 200mg, twice daily (400mg/day)
Matching Placebo (Placebo oral capsule)
Outcomes
Primary Outcome Measures
Incidence of AF
Between group incidence of post-operative AF
Secondary Outcome Measures
Length of hospital stay (LoHS) after surgery
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)
Short-Form 36 Questionnaires (SF-36)
Full Information
NCT ID
NCT03807037
First Posted
January 14, 2019
Last Updated
August 23, 2022
Sponsor
Monash University Malaysia
Collaborators
Institut Jantung Negara
1. Study Identification
Unique Protocol Identification Number
NCT03807037
Brief Title
Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
Official Title
Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Monash University Malaysia
Collaborators
Institut Jantung Negara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation,tocotrienol,coronary artery bypass grafting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Mixed tocotrienols 200mg, twice daily (400mg/day)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Matching Placebo (Placebo oral capsule)
Intervention Type
Dietary Supplement
Intervention Name(s)
Tocotrienols
Other Intervention Name(s)
Tocovid Suprabio
Intervention Description
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Matching placebo to be administered orally at 1 capsule, twice daily
Primary Outcome Measure Information:
Title
Incidence of AF
Description
Between group incidence of post-operative AF
Time Frame
24-48 hours post-operation, up to 6-weeks after discharge
Secondary Outcome Measure Information:
Title
Length of hospital stay (LoHS) after surgery
Description
Total Intensive/coronary care unit length of stay,
Total days of High Dependency Unit stay;
Total hospital length of stay
Time Frame
Up to 2 months post-operation
Title
Health-related quality of life (HRQoL)
Description
Short-Form 36 Questionnaires (SF-36)
Time Frame
6-weeks after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Farouk Musa, MD
Organizational Affiliation
Monash University Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34819126
Citation
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.
Results Reference
derived
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Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
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