Atrial FibrillationPhase 3NCT01999829
Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
A Phase 3 study testing citrate of caffeine in people with Atrial Fibrillation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- citrate of caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jun 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age = 18 years
- Surgery valvular settled(adjusted) (plasties or aortic replacement, mitral, tricuspid or mixed), under CEC
- Period of weaning in caffeine: limitation of the consumption of coffee(café), tea, chocolate, in a cup the day before the intervention
- Consent of the patients after information
Who cannot join
- Pregnant or breast-feeding women
- Women taking an oral contraception (half-life of the caffeine increased until 3 times)
- Minors(miners) or adults under guardianship
- Persons staying in a sanitary or social establishment
- Not profitable persons of a national insurance scheme
- Private persons of freedom
Show all 10Show fewer
- Persons requiring a surgery of replacement valvular as a matter of urgency
- Patients having been treated(handled) by papaverine, dipyridamole, corticoids, immunosuppressors or antibiotics during six weeks preceding the date of inclusion
- Weighty patient lower than 50 kg or upper to 100 kg or having a body mass index upper to 29 Kg / m2
- Presence of an active infection, a chronic inflammatory pathology, a lung arterial high blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.
The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.
The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.
- Conditions
- Atrial Fibrillation
- Being tested
- citrate of caffeine, placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citrate of caffeineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| citrate of caffeine | Experimental | Not described Receives: Drug: citrate of caffeine |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of 50 % of the incidence of atrial fibrillation
Measured: 24 MONTHS
Secondary outcomes (1)
decrease in the use of anti-arrhythmic resuscitation
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999829
- Sponsor's protocol ID
- 2013-23
- Other IDs
- 2013-23
- Status last verified
- Aug 2015
- First submitted
- 26 Sep 2013
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lagier D, Nee L, Guieu R, Kerbaul F, Fenouillet E, Roux N, Giorgi R, Theron A, Grisoli D, Gariboldi V, Collart F, Bruder N, Velly L, Guidon C. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial. Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.
PubMed 29702502
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
- ClinicalTrials.gov ID
- NCT01999829
- Acronym / sponsor ID
- 2013-23
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Dec 2013 (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.
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.
The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.
The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citrate of caffeine | Experimental | Drug: citrate of caffeine |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age = 18 years
- Surgery valvular settled(adjusted) (plasties or aortic replacement, mitral, tricuspid or mixed), under CEC
- Period of weaning in caffeine: limitation of the consumption of coffee(café), tea, chocolate, in a cup the day before the intervention
- Consent of the patients after information
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding women
- Women taking an oral contraception (half-life of the caffeine increased until 3 times)
- Minors(miners) or adults under guardianship
- Persons staying in a sanitary or social establishment
- Not profitable persons of a national insurance scheme
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 |
|---|---|---|
| citrate of caffeine | Drug | citrate of caffeine |
| placebo | Drug | placebo |
Primary outcome
Decrease of 50 % of the incidence of atrial fibrillation
Time frame: 24 MONTHS
1 secondary outcome
decrease in the use of anti-arrhythmic resuscitation
Time frame: 24 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Derived from this study: PubMed 29702502Lagier D, Nee L, Guieu R, Kerbaul F, Fenouillet E, Roux N, Giorgi R, Theron A, Grisoli D, Gariboldi V, Collart F, Bruder N, Velly L, Guidon C. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial. Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.
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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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
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 citrate of caffeine in people with Atrial Fibrillation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 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 14 Mar 2017. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease of 50 % of the incidence of atrial fibrillation (time frame: 24 MONTHS). 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 NCT01999829, 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 14 Mar 2017.