Atrial FibrillationPhase 3PROFACENCT01570530
Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery
A Phase 3 study testing Cardiac surgery in people with Atrial Fibrillation, run by Fundación General Universidad de Valladolid at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 year-old.
- In sinus rhythm.
- Affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
- Women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.
Who cannot join
- Urgent surgery.
- Surgery due to endocarditis.
- Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
- Treatment with beta-blockers at time of randomization
- Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
- Chronic using of NSAIDs and / or corticosteroids at time of randomization
Show all 19Show fewer
- Uncontrolled thyroid disease.
- Active liver disease and / or history of previous chronic liver disease.
- Alcoholism.
- Predisposing factors to statins adverse effects:
- Increased transaminase levels at baseline (x3 normal value).
- Renal failure (creatinine levels over 2 mg/dl).
- Previous diagnosis of myopathy of any etiology.
- Known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
- In women of childbearing age, positive pregnancy test the day of inclusion in the study.
- Not signed informed consent.
- Inability to understand objectives of the study.
- Withdrawal of patient's consent.
- Modification in liver laboratory parameters (transaminases above three times normal value) and / or creatine-fosfokinase level suggesting adverse effects of statins.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47005
About this study
The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiac surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Cardiac surgeryProcedure or surgery
Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Patients treated with atorvastatin Receives: Procedure: Cardiac surgery |
| Without Atorvastatin | Other | Patients treated without atorvastatin Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative atrial fibrillation(atorvastatin and control groups)
To evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs or statins.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Secondary outcomes (6)
Changes in inflammatory markers values during extracorporeal circulation, and postoperative atrial fibrillation.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Changes in biochemical markers in both groups.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Changes in echocardiographic parameters in both groups.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Frequency, duration, characteristics and risk factors for postoperative atrial fibrillation in patients with valve disease (without history of previous arrhythmia) undergoing cardiac surgery.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Clinical and hemodynamic consequences of postoperative atrial fibrillation after cardiac surgery.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Prolongation of in-hospital and Intensive Care Unit (ICU) stay and the need for new drug or interventionism therapies, directly related to its appearance.
Measured: Participants will be followed for the duration of hospital day, an expected average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2014
- Study completionSep 2014
Why it stopped: End of finantial support
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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación General Universidad de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yolanda Carrascal Hinojal, M.D, Principal investigator, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570530
- Sponsor's protocol ID
- PROFACE
- Acronym
- PROFACE
- Status last verified
- Sep 2014
- First submitted
- 1 Mar 2012
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01570530
- Acronym / sponsor ID
- PROFACE / PROFACE
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of finantial support
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fundación General Universidad de ValladolidUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 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 evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Procedure: Cardiac surgeryPatients treated with atorvastatin |
| Without Atorvastatin | Other | Procedure: Cardiac surgeryPatients treated without atorvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18 year-old.
- In sinus rhythm.
- Affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
- Women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.
Key exclusion criteria (19 listed)
- Urgent surgery.
- Surgery due to endocarditis.
- Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
- Treatment with beta-blockers at time of randomization
- Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
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 |
|---|---|---|
| Cardiac surgeryAtorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery | Procedure or surgery | Atorvastatin |
| Cardiac surgeryWithout atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery | Procedure or surgery | Without Atorvastatin |
Primary outcome
Number of patients with postoperative atrial fibrillation(atorvastatin and control groups)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
To evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs or statins.
6 secondary outcomes
Changes in inflammatory markers values during extracorporeal circulation, and postoperative atrial fibrillation.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Changes in biochemical markers in both groups.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Changes in echocardiographic parameters in both groups.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Frequency, duration, characteristics and risk factors for postoperative atrial fibrillation in patients with valve disease (without history of previous arrhythmia) undergoing cardiac surgery.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Clinical and hemodynamic consequences of postoperative atrial fibrillation after cardiac surgery.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Prolongation of in-hospital and Intensive Care Unit (ICU) stay and the need for new drug or interventionism therapies, directly related to its appearance.
Time frame: Participants will be followed for the duration of hospital day, an expected average of 10 days.
Results and safety
The study was stopped early (reason given: End of finantial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Yolanda Carrascal Hinojal, M.D principal investigator
Hospital Clínico Universitario de Valladolid
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 Cardiac surgery in people with Atrial Fibrillation, run by Fundación General Universidad de Valladolid at 1 site in Spain.
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 19 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: stopped early, as of the sponsor's last update on 16 Sep 2014. 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 Spain. 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?
The study was stopped early (reason given: End of finantial support). Results are not available in the source record.
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?
Number of patients with postoperative atrial fibrillation(atorvastatin and control groups) (time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 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 16 Sep 2014.