Back to resultsAtorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery (PROFACE)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Cardiac surgery
Cardiac surgery
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Exclusion criteria of the study once started:
- 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.
Sites / Locations
- Hospital Clínico Universitario de Valladolid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Atorvastatin
Without Atorvastatin
Arm Description
Patients treated with atorvastatin
Patients treated without atorvastatin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in inflammatory markers values during extracorporeal circulation, and postoperative atrial fibrillation.
Changes in biochemical markers in both groups.
Changes in echocardiographic parameters in both groups.
Frequency, duration, characteristics and risk factors for postoperative atrial fibrillation in patients with valve disease (without history of previous arrhythmia) undergoing cardiac surgery.
Clinical and hemodynamic consequences of postoperative atrial fibrillation after cardiac surgery.
Prolongation of in-hospital and Intensive Care Unit (ICU) stay and the need for new drug or interventionism therapies, directly related to its appearance.
Full Information
NCT ID
NCT01570530
First Posted
March 1, 2012
Last Updated
September 15, 2014
Sponsor
Fundación General Universidad de Valladolid
1. Study Identification
Unique Protocol Identification Number
NCT01570530
Brief Title
Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery
Acronym
PROFACE
Official Title
Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
End of finantial support
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación General Universidad de Valladolid
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 previous history of atrial fibrillation and not receiving beta-blocking drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Patients treated with atorvastatin
Arm Title
Without Atorvastatin
Arm Type
Other
Arm Description
Patients treated without atorvastatin
Intervention Type
Procedure
Intervention Name(s)
Cardiac surgery
Intervention Description
Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Intervention Type
Procedure
Intervention Name(s)
Cardiac surgery
Intervention Description
Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Primary Outcome Measure Information:
Title
Number of patients with postoperative atrial fibrillation(atorvastatin and control groups)
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Exclusion criteria of the study once started:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolanda Carrascal Hinojal, M.D
Organizational Affiliation
Hospital Clínico Universitario de Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery
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