- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807037
Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Kuala Lumpur, Malaysia, 50400
- Institut Jantung Negara
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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)
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Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Other Names:
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Placebo Comparator: Control
Matching Placebo (Placebo oral capsule)
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Matching placebo to be administered orally at 1 capsule, twice daily
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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
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Between group incidence of post-operative AF
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24-48 hours post-operation, up to 6-weeks after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay (LoHS) after surgery
Time Frame: Up to 2 months post-operation
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Up to 2 months post-operation
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Health-related quality of life (HRQoL)
Time Frame: 6-weeks after discharge
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Short-Form 36 Questionnaires (SF-36)
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6-weeks after discharge
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmad Farouk Musa, MD, Monash University Malaysia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T3-AF 34963
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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