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NCT00953212 · ClinicalTrials.gov registry record · Phase 3
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
A Phase 3 study of Atrial Fibrillation and Atrial Flutter, sponsored by MaineHealth.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 1
- Study location
NCT00953212: Completed Phase 3 study of Atrial Fibrillation and Atrial Flutter, sponsored by MaineHealth.
NCT00953212 is a Phase 3 study of Atrial Fibrillation and Atrial Flutter that has completed, run by MaineHealth. The registered enrollment target is 304 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00953212, a Phase 3 study of Atrial Fibrillation and Atrial Flutter, has completed, sponsored by MaineHealth.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 1
- Study location
Study Summary
Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients. Efforts to decrease the high rates of AF have not made great inroads to the problem. The current standard of care is the use of preoperative and postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid with and without prophylactic oral amiodarone, in combination with oral beta blockers, for the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either drug, or a combination of the two drugs, will be superior and safe when compared to beta blockers alone.
Primary Outcome
Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease th
Conditions Studied
Interventions
- DRUG ascorbic acid
- DRUG beta blockers
- DRUG amiodarone
Study Locations (1)
Maine
- Maine Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT00953212 record still lists
NCT00953212 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 3 interventions - of which ascorbic acid is the first listed.
NCT00953212 reports a single indexed study location in Maine.
Frequently Asked Questions
What is clinical trial NCT00953212 about?
NCT00953212 is a clinical study titled "Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery". Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients. Efforts to decrease the high rates of AF have not made great inroads to the prob...
What is the current status of trial NCT00953212?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2009-08. Estimated completion is 2012-02.
What conditions does trial NCT00953212 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter.
What interventions are being tested in trial NCT00953212?
The interventions under investigation include: ascorbic acid (DRUG), beta blockers (DRUG), amiodarone (DRUG).
Who is sponsoring clinical trial NCT00953212?
This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00953212 being conducted?
This trial has 1 study location across Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00953212's enrollment target sits among peer trials
304 82nd of 202 higher than 121 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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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