Trials / Completed
CompletedNCT03807037
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Monash University Malaysia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DRUG | Placebo oral capsule | Matching placebo to be administered orally at 1 capsule, twice daily |
Timeline
- Start date
- 2018-12-17
- Primary completion
- 2021-12-30
- Completion
- 2021-12-30
- First posted
- 2019-01-16
- Last updated
- 2022-08-25
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT03807037. Inclusion in this directory is not an endorsement.