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

This study is currently recruiting participants.
Verified March 2012 by Fundación General Universidad de Valladolid
Sponsor:
Information provided by (Responsible Party):
Fundación General Universidad de Valladolid
ClinicalTrials.gov Identifier:
NCT01570530
First received: March 1, 2012
Last updated: April 17, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Procedure: Cardiac surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundación General Universidad de Valladolid:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: January 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
Patients treated with atorvastatin
 Procedure: Cardiac surgery
Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
Without Atorvastatin
Patients treated without atorvastatin
 Procedure: Cardiac surgery
Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570530

Contacts
Contact: Yolanda Carrascal Hinojal, M.D 34 983 420 000 ext 377 ycarrascal@hotmail.com
Contact: Yolanda Calvo 34 983 423 548 yolanda@funge.uva.es

Locations
Spain
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain, 47005
Contact: Yolanda Carrascal Hinojal, M.D     34 983 420 000 ext 377     ycarrascal@hotmail.com    
Contact: Yolanda Calvo     34 983 186 352     yolanda@funge.uva.es    
Principal Investigator: Yolanda Carrascal Hinojal, M.D            
Sponsors and Collaborators
Fundación General Universidad de Valladolid
Investigators
Principal Investigator: Yolanda Carrascal Hinojal, M.D Hospital Clínico Universitario de Valladolid
  More Information

No publications provided

Responsible Party: Fundación General Universidad de Valladolid
ClinicalTrials.gov Identifier: NCT01570530     History of Changes
Other Study ID Numbers: PROFACE
Study First Received: March 1, 2012
Last Updated: April 17, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013