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

NCT01570530 | Terminated Phase 3

• 1 other identifier: PROFACE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• 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.

• 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.

• 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.

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Patients treated with atorvastatin

Procedure: Cardiac surgery

Without Atorvastatin

OTHER

Patients treated without atorvastatin

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery

Atorvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Not signed informed consent.

Sponsors & Collaborators

• Fundación General Universidad de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47005, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Yolanda Carrascal Hinojal, M.D

  Hospital Clínico Universitario de Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: April 4, 2012
• Study Start: January 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

ES (1)