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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atorvastatin

Patients treated with atorvastatin

Group Type ACTIVE_COMPARATOR

Cardiac surgery

Intervention Type PROCEDURE

Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

Without Atorvastatin

Patients treated without atorvastatin

Group Type OTHER

Cardiac surgery

Intervention Type PROCEDURE

Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

Interventions

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Cardiac surgery

Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

Intervention Type PROCEDURE

Cardiac surgery

Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No