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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00953212
The ClinicalTrials.gov registry entry for NCT00953212 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (90% lower). The listed sponsor is MaineHealth, which has 26 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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