Atrial FibrillationPhase 3NCT01107730
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
A Phase 3 study testing Vitamin C and L-Carnitine in people with Atrial Fibrillation, run by Attikon Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vitamin C and L-Carnitine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Apr 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing on-pump cardiac surgery
Who cannot join
- Off-pump cardiac surgery procedure
- AF before the procedure
- Recent infection and/or infectious endocarditis
- Presence of neoplasia
- Chronic renal failure with creatinine>2.3 mg/dl
- Hepatic failure
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- Autoimmune disease and/or disease that brings about a systematic inflammatory response
- Thyroid disease
- Systematic use of supplements that contain vitC or carnitine
- The use of NSAIDs other than aspirin for a time period up to one month before the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
Read the detailed description
Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Vitamin C, L-Carnitine, Placebo
- Keywords
- Atrial fibrillation, Cardiac valve repair, Aneurysm repair, CABG, On-pump, Cardiac surgery, Vitamin C
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
L-CarnitineDrug
L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| L-Carnitine | Active comparator | L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days Receives: Drug: L-Carnitine |
| Vitamin C | Active comparator | VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days Receives: Drug: Vitamin C |
| Placebo | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Atrial Fibrillation
The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.
Measured: Within the first 30 days (plus or minus 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polymeropoulos Evangelos, Attikon Hospital
- Investigators
- Ioannis Toumpoulis, MD, Study chair, University of Athens Medical School, Attikon Hospital, Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107730
- Sponsor's protocol ID
- 268/27-07-09
- Status last verified
- Sep 2015
- First submitted
- 20 Apr 2010
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rodrigo R, Vinay J, Castillo R, Cereceda M, Asenjo R, Zamorano J, Araya J, Castillo-Koch R, Espinoza J, Larrain E. Use of vitamins C and E as a prophylactic therapy to prevent postoperative atrial fibrillation. Int J Cardiol. 2010 Feb 4;138(3):221-8. doi: 10.1016/j.ijcard.2009.04.043. Epub 2009 May 15.
PubMed 19446899
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
- ClinicalTrials.gov ID
- NCT01107730
- Acronym / sponsor ID
- 268/27-07-09
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Cardiac valve repair, Aneurysm repair, CABG, On-pump, Cardiac surgery, Vitamin C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 13 May 2015
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 whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
Detailed description
Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-Carnitine | Active comparator | Drug: L-CarnitineL-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days |
| Vitamin C | Active comparator | Drug: Vitamin CVitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days |
| Placebo | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing on-pump cardiac surgery
Key exclusion criteria (10 listed)
- Off-pump cardiac surgery procedure
- AF before the procedure
- Recent infection and/or infectious endocarditis
- Presence of neoplasia
- Chronic renal failure with creatinine>2.3 mg/dl
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 |
|---|---|---|
| Vitamin CVitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days | Drug | Vitamin C |
| L-CarnitineL-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days | Drug | L-Carnitine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Incidence of Postoperative Atrial Fibrillation
Time frame: Within the first 30 days (plus or minus 3 days)
The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19446899Rodrigo R, Vinay J, Castillo R, Cereceda M, Asenjo R, Zamorano J, Araya J, Castillo-Koch R, Espinoza J, Larrain E. Use of vitamins C and E as a prophylactic therapy to prevent postoperative atrial fibrillation. Int J Cardiol. 2010 Feb 4;138(3):221-8. doi: 10.1016/j.ijcard.2009.04.043. Epub 2009 May 15.
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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.
Ioannis Toumpoulis, MD study chair
University of Athens Medical School, Attikon Hospital, Cardiology Department
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 Vitamin C and L-Carnitine in people with Atrial Fibrillation, run by Attikon Hospital at 1 site in Greece.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 19 Oct 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 Greece. 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. 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?
Yes. Results are posted in the registry (first posted 13 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Postoperative Atrial Fibrillation (time frame: Within the first 30 days (plus or minus 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107730, which also lists 1 linked publication.
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 19 Oct 2015.