Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery (PROFACE)

September 15, 2014 updated by: Fundación General Universidad de Valladolid
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women over 18 year-old.
  2. In sinus rhythm.
  3. Affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
  4. Women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.

Exclusion Criteria:

  1. Urgent surgery.
  2. Surgery due to endocarditis.
  3. Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
  4. Treatment with beta-blockers at time of randomization
  5. Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
  6. Chronic using of NSAIDs and / or corticosteroids at time of randomization
  7. Uncontrolled thyroid disease.
  8. Active liver disease and / or history of previous chronic liver disease.
  9. Alcoholism.

  10. 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.
  11. Known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
  12. In women of childbearing age, positive pregnancy test the day of inclusion in the study.
  13. Not signed informed consent.
  14. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin
Patients treated with atorvastatin
Procedure: Cardiac surgery
Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Procedure: Cardiac surgery
Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Other: Without Atorvastatin
Patients treated without atorvastatin
Procedure: Cardiac surgery
Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Procedure: Cardiac surgery
Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for the duration of hospital stay, an expected average of 10 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.
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.
Participants will be followed for the duration of hospital day, an expected average of 10 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación General Universidad de Valladolid

Investigators

  • Principal Investigator: Yolanda Carrascal Hinojal, M.D, Hospital Clínico Universitario de Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROFACE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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