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

Atrial Fibrillation Clinical Trial

— PROFACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01570530
• Other study ID #: PROFACE
• Status: Terminated
• Phase: Phase 3
• First received: March 1, 2012
• Last updated: September 15, 2014
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Fundación General Universidad de Valladolid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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 previous history of atrial fibrillation and not receiving beta-blocking drugs.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Cardiac surgery
Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
• Cardiac surgery
Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación General Universidad de Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	No
Secondary	Changes in inflammatory markers values during extracorporeal circulation, and postoperative atrial fibrillation.		Participants will be followed for the duration of hospital stay, an expected average of 10 days.	No
Secondary	Changes in biochemical markers in both groups.		Participants will be followed for the duration of hospital stay, an expected average of 10 days.	No
Secondary	Changes in echocardiographic parameters in both groups.		Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Yes
Secondary	Frequency, duration, characteristics and risk factors for postoperative atrial fibrillation in patients with valve disease (without history of previous arrhythmia) undergoing cardiac surgery.		Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Yes
Secondary	Clinical and hemodynamic consequences of postoperative atrial fibrillation after cardiac surgery.		Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Yes
Secondary	Prolongation of in-hospital and Intensive Care Unit (ICU) stay and the need for new drug or interventionism therapies, directly related to its appearance.		Participants will be followed for the duration of hospital day, an expected average of 10 days.	No