Status:
COMPLETED
Safety and Efficacy of Tocotrienols in Post-CABG Atrial Fibrillation
Lead Sponsor:
Monash University Malaysia
Collaborating Sponsors:
Institut Jantung Negara
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 fail...
Eligibility Criteria
Inclusion
- Males or females
- More than 18 years of age
- Elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery
Exclusion
- 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
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03807037
Start Date
December 17 2018
End Date
December 30 2021
Last Update
August 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Jantung Negara
Kuala Lumpur, Malaysia, 50400