Atrial FibrillationPhase 3NCT01580683
Vitamin C and Atrial Fibrillation After Cardiac Surgery
A Phase 3 study testing Ascorbic Acid in people with Atrial Fibrillation, run by Regional Hospital of Scranton at 1 site in United States.
Trial summary
The purpose of this study is to determine if vitamin C decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 50 years of age or older
- Undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two
Who cannot join
- Prior cardiac surgery
- History of atrial fibrillation
- Permanent or temporary pace maker
- Currently taking digoxin or Vaughan Williams Class I or III antiarrhythmic medications
- Known hyperoxaluria
- History of renal calculi
- History of allergic or hypersensitivity reaction to ascorbic acid products
- Currently taking 1 g or more of ascorbic acid supplementation daily
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Hospital of Scranton
Scranton, Pennsylvania, 18510
About this study
Official title: Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
The purpose of this study is to determine if vitamin C decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. It poses extra risks to people who develop it. Our hypothesis is that Vitamin C will decrease the incidence of postoperative atrial fibrillation.
Read the detailed description
The development of atrial fibrillation (AF) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. Coronary artery bypass graft surgery (CABG) carries the lowest risk of AF development, with an incidence of approximately 25-30%, followed by cardiac valve and combined CABG/cardiac valve surgeries, with incidences up to 60%. AF development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the ICU, stroke, reintubation, and 30-day and 6-month mortality. Patients who develop AF have also been shown to experience longer hospital stays, both in the ICU and overall.
While some other medications have been shown to decrease the risk of AF development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing CABG surgery. However, patients experiencing AF have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that AF occurs through oxidative stress. Due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of AF development following cardiac surgery. Ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and AF development following cardiac surgery. This trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative AF in patients undergoing elective or urgent CABG surgery, cardiac valve surgery, or a combination of the two. Our hypothesis is that ascorbic acid will decrease the incidence of postoperative AF development.
- Conditions
- Atrial Fibrillation
- Being tested
- Ascorbic Acid, Identical Placebo
- Keywords
- Atrial Fibrillation, Ascorbic Acid, Thoracic Surgery, Cardiac Arrhythmias, Cardiac Surgery, Vitamin C, Postoperative Complications, Antioxidants, Inflammation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Postoperative Complications, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C
Two 1 g capsules the evening prior to surgery, followed by one 1 g capsule every 12 hours starting the morning of the first postoperative day for 5 days.
Identical PlaceboOther
Two capsules the evening prior to surgery, followed by one capsule every 12 hours starting the morning of the first postoperative day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid | Experimental | Not described Receives: Drug: Ascorbic Acid |
| Placebo | Placebo comparator | Not described Receives: Other: Identical Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative atrial fibrillation
Measured: Patients will be followed for the entire hospital stay, with an expected average of 5 days
Secondary outcomes (6)
Hospital length of stay
Measured: 30 Days
Intensive care unit length of stay
Measured: 30 Days
Stroke
Measured: 30 Days
Transient ischemic attack
Measured: 30 Days
Mortality
Measured: 30 Days
Hospital Readmission for atrial fibrillation
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: No funding obtained to support patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital of Scranton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Bolesta, Pharm.D., BCPS, Regional Hospital of Scranton
- Investigators
- Scott Bolesta, Pharm.D., Principal investigator, Wilkes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580683
- Sponsor's protocol ID
- WU0811SB
- Status last verified
- May 2015
- First submitted
- 13 Apr 2012
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01580683
- Acronym / sponsor ID
- WU0811SB
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ascorbic Acid, Thoracic Surgery, Cardiac Arrhythmias, Cardiac Surgery, Vitamin C, Postoperative Complications, Antioxidants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained to support patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regional Hospital of ScrantonUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if vitamin C decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. It poses extra risks to people who develop it. Our hypothesis is that Vitamin C will decrease the incidence of postoperative atrial fibrillation.
Detailed description
The development of atrial fibrillation (AF) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. Coronary artery bypass graft surgery (CABG) carries the lowest risk of AF development, with an incidence of approximately 25-30%, followed by cardiac valve and combined CABG/cardiac valve surgeries, with incidences up to 60%. AF development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the ICU, stroke, reintubation, and 30-day and 6-month mortality. Patients who develop AF have also been shown to experience longer hospital stays, both in the ICU and overall.
While some other medications have been shown to decrease the risk of AF development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing CABG surgery. However, patients experiencing AF have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that AF occurs through oxidative stress. Due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of AF development following cardiac surgery. Ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and AF development following cardiac surgery. This trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative AF in patients undergoing elective or urgent CABG surgery, cardiac valve surgery, or a combination of the two. Our hypothesis is that ascorbic acid will decrease the incidence of postoperative AF development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid | Experimental | Drug: Ascorbic Acid |
| Placebo | Placebo comparator | Other: Identical Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 50 years of age or older
- Undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two
Key exclusion criteria (8 listed)
- Prior cardiac surgery
- History of atrial fibrillation
- Permanent or temporary pace maker
- Currently taking digoxin or Vaughan Williams Class I or III antiarrhythmic medications
- Known hyperoxaluria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin CTwo 1 g capsules the evening prior to surgery, followed by one 1 g capsule every 12 hours starting the morning of the first postoperative day for 5 days. | Drug | Ascorbic acid |
| Identical PlaceboTwo capsules the evening prior to surgery, followed by one capsule every 12 hours starting the morning of the first postoperative day for 5 days. | Other | Placebo |
Primary outcome
Post-operative atrial fibrillation
Time frame: Patients will be followed for the entire hospital stay, with an expected average of 5 days
6 secondary outcomes
Hospital length of stay
Time frame: 30 Days
Intensive care unit length of stay
Time frame: 30 Days
Stroke
Time frame: 30 Days
Transient ischemic attack
Time frame: 30 Days
Mortality
Time frame: 30 Days
Hospital Readmission for atrial fibrillation
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Bolesta, Pharm.D. principal investigator
Wilkes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ascorbic Acid in people with Atrial Fibrillation, run by Regional Hospital of Scranton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative atrial fibrillation (time frame: Patients will be followed for the entire hospital stay, with an expected average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.