Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
NCT ID: NCT03807037
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
250 participants
INTERVENTIONAL
2018-12-17
2021-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment
Mixed tocotrienols 200mg, twice daily (400mg/day)
Tocotrienols
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Control
Matching Placebo (Placebo oral capsule)
Placebo oral capsule
Matching placebo to be administered orally at 1 capsule, twice daily
Interventions
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Tocotrienols
Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
Placebo oral capsule
Matching placebo to be administered orally at 1 capsule, twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. More than 18 years of age
3. Elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Institut Jantung Negara
OTHER
Monash University Malaysia
OTHER
Responsible Party
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Principal Investigators
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Ahmad Farouk Musa, MD
Role: PRINCIPAL_INVESTIGATOR
Monash University Malaysia
Locations
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Institut Jantung Negara
Kuala Lumpur, , Malaysia
Countries
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References
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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.
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.
Other Identifiers
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T3-AF 34963
Identifier Type: -
Identifier Source: org_study_id
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