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NCT02762331 · ClinicalTrials.gov registry record · Phase 1
High Dose Vitamin C in Cardiac Surgery Patients
A Phase 1 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02762331: Clinical Trial Phase 1 study, sponsored by Virginia Commonwealth University.
NCT02762331 is a Phase 1 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02762331, a Phase 1 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third post-operative day. Reduction of AF by various drugs is moderately effective, but involves either rate control with beta blockers or rate conversion with amiodarone after the myocardial damage processes initiating AF have already occurred. Decreasing the incidence of post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be more fruitfully approached by targeting the upstream combined processes of inflammation and coagulation activation induced by the surgical insult and associated ischemia-reperfusion (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be prevented and/or inhibited by antioxidant supplementation. Specifically the investigators hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and therefore damp down upstream inflammatory processes, leading to a reduction of downstream adverse events with demonstrable links to inflammation processes, such as AF.
Primary Outcome
Change in baseline inflammatory biomarkers including TNF-alpha, C-reactive protein, and interleukin-6 will be measured at 6, 24, and 48 hours following first administration of study drug.
Interventions
- DRUG Placebo
- DRUG Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2018-03-13 |
| Phase | Phase 1 |
Why NCT02762331 stopped before completion
NCT02762331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02762331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02762331 about?
NCT02762331 is a clinical study titled "High Dose Vitamin C in Cardiac Surgery Patients". Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third post-operative day. Reduction...
What is the current status of trial NCT02762331?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-01-01. Estimated completion is 2018-03-13.
What interventions are being tested in trial NCT02762331?
The interventions under investigation include: Placebo (DRUG), Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT02762331?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02762331's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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