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

Phase 3

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT01570530
• Lead Sponsor: Fundación General Universidad de Valladolid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2014-06
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Cardiac surgery	Patients treated with atorvastatin
Without Atorvastatin	Cardiac surgery	Patients treated without atorvastatin

Primary Outcome Measures

Name	Time	Method
Number of patients with postoperative atrial fibrillation(atorvastatin and control groups)	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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
Changes in biochemical markers in both groups.	Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Changes in echocardiographic parameters in both groups.	Participants will be followed for the duration of hospital stay, an expected average of 10 days.

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain