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

Fundación General Universidad de Valladolid

Status and phase

Terminated

Phase 3

Conditions

Atrial Fibrillation

Treatments

Procedure: Cardiac surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01570530

PROFACE

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Urgent surgery.
Surgery due to endocarditis.
Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
Treatment with beta-blockers at time of randomization
Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
Chronic using of NSAIDs and / or corticosteroids at time of randomization
Uncontrolled thyroid disease.
Active liver disease and / or history of previous chronic liver disease.
Alcoholism.
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.
Known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
In women of childbearing age, positive pregnancy test the day of inclusion in the study.
Not signed informed consent.
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.