POST-OPERATIVE ATRIAL FIBRILLATION MedDRA version: 13 Level: SOC Classification code 10003658
Conditions
Interventions
Trade Name: LIPITOR
Product Name: ATORVASTATIN CALCIUM
Pharmaceutical Form: Coated tablet
INN or Proposed INN: (R—(R*, R*))-2-(4-fluorophenyl)-ß,d-dihydroxy-5-(1-methylethyl)-3-phenyl-4((phenylamino)c
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the effect of perioperative administration of high-dose atorvastatin on the activity of atrial oxidase systems (the enzymes producing reactive oxygen species in the atrial tissue),inflammation in atrial tissue,on the postoperative AF burden (evaluated by ambulatory ECG monitoring)and contractile function of the heart. ;Main Objective: To establish whether perioperative administration (for 6 to 1 day before surgery and 5 days after) of atorvastatin (80 mg od) in patients undergoing elective cardiac surgery •Prevents shortening of the atrial effective refractory period (a marker of atrial electrical remodelling leading to AF)after surgery •Leads to a reduction in atrial production of reactive oxygen species (an independent predictor of post-operative AF)and systemic inflammatory markers. ;Primary end point(s): To establish whether perioperative administration (for 6 to 1 day before surgery and 5 days after) of atorvastatin (80 mg od) in patients undergoing elective cardiac surgery •Prevents shortening of the atrial effective refractory period in the postoperative period •Leads to a reduction in atrial production of reactive oxygen species and systemic markers of inflammation and cardiac function | — |
Countries
United Kingdom
Outcome results
None listed