Prevention of atrial oxidative stress and electrical remodelling in patients undergoing cardiac surgery: randomised placebo-controlled trial of perioperative high-dose atorvastatin - Do statins prevent atrial rhythm disturbances after cardiac surgery?

• Conditions: POST-OPERATIVE ATRIAL FIBRILLATION; MedDRA version: 13Level: SOCClassification code 10003658

• Registration Number: EUCTR2009-013228-21-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who are:
1. Willing and able to give informed consent for participation in the study
2. In normal sinus rhythm at the time of surgery
3. Stable and requiring elective cardiac surgery.
4. Able (in the Investigators’ opinion) and willing to comply with all study requirements.
5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Age>80yrs
? Female participant who is pregnant, lactating or planning pregnancy during the
course of the study.
? Women of child-bearing potential without appropriate contraceptive measures. These
include oral contraceptive pills, Intrauterine contraceptive devices etc
? History of obstructive hepatobiliary disease or other serious hepatic disease or preoperative ALT >2-fold the upper limit of normal or alcohol abuse
? Creatinine >200 umol/L
? Untreated hypothyroidism
? Family history of hereditary muscle disorders
? Known intolerance to statins or history of muscle toxicity with fibrates or statins.
? Ongoing use of fibrates, niacin or of agents that are strong inhibitors of cytochrome
P-450 or the P-glycoprotein within a month preceding randomization (cyclosporine,
azole antifungals, such as itraconazole and ketoconazole, macrolide antibiotics, such
as erythromycin and clarithromycin, protease inhibitors, nefazodone, verapamil,
amiodarone or large quantity of grapefruit juice (= 1L/day) Patients on treatment with anti arrhythmic agents, other than beta-adrenergic receptor blockers.
? Participant who is terminally ill or is inappropriate for placebo medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified