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| Name | Class |
|---|---|
| Institut Jantung Negara | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Mixed tocotrienols 200mg, twice daily (400mg/day) |
|
| Control | Placebo Comparator | Matching Placebo (Placebo oral capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienols | Dietary Supplement | Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AF | Between group incidence of post-operative AF | 24-48 hours post-operation, up to 6-weeks after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (LoHS) after surgery |
| Up to 2 months post-operation |
| Health-related quality of life (HRQoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Farouk Musa, MD | Monash University Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076222 | Derived | 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. | |
| 34819126 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Placebo oral capsule | Drug | Matching placebo to be administered orally at 1 capsule, twice daily |
|
Short-Form 36 Questionnaires (SF-36)
| 6-weeks after discharge |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |