patients after successful cardioversion of atrial fibrillation
Conditions
Interventions
Trade Name: Zocord
Product Name: Zocord
Product Code: n.a.
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Medical University of Vienna, Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age>18yrs -At least second episode of non valvular, persistent, symptomatic AF within one year, defined by an echocardiogram asserting non valvular origin and a duration of at least 12 hours. -Patient willing to undergo cardioversion if no spontaneous conversion to sinus rhythm occurs within 12 hours -Written informed consent 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: -First episode of AF -Last episode longer than a year ago -Termination within 12 hours -Transient atrial fibrillation caused by known reversible disorders (thyrotoxicosis, alcohol intoxication etc.) -Known refractoriness to cardioversion (after several trials, permanent AF) -Severe valvular heart disease -Current atrial myxoma or left ventricular thrombus -Left Ventricular Ejection Fraction 500ms) -Stroke within the previous 30 days or transient ischaemic attack within 3 days -Treatment with fibrinolytic agents within 30 days before randomisation -History of intracranial, intraocular, spinal, retroperitoneal, overt gastrointestinal or atraumatic intra-articular bleeding during the last year -Endoscopically verified ulcer disease in the previous 30 days -Major surgical procedure or trauma in the previous 30 days -Planned major surgery -Haemorrhagic disorder -Admission for acute coronary syndrome or percutaneous coronary intervention within 30 days -Persistent blood pressure 180/100 mm Hg or greater with or without antihypertensive treatment -Need for regular use of non-steroidal anti-inflammatory at anti-inflammatory doses -Renal insufficiency (calculated creatinine clearance 5 mmol/L) -Estimated life expectancy <2 years -Already receiving statin therapy and need for statin therapy -Explicit need for statin therapy: Persons with established CHD or CHD risk equivalent (i.e. PAD or diabetes mellitus), who have a baseline LDL cholesterol =130 mg/dL -Known hypersensitivity to statins -Lipid-lowering therapy with fibric acid derivatives or niacin that cannot be discontinued before randomization, -Drugs that are strong inhibitors of cytochrome P-450 3A4 within the month before randomization or patients likely to require such treatment during the study period (because simvastatin is metabolized by this pathway)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of statin treatment on (hs)-CRP-levels;Secondary Objective: To investigate the effects of statin treatment on the following: -Recurrence rate and time to recurrence of AF -Established risk markers including lipid subfractions and other biomarkers of cardiovascular risk in AF (such as von Willebrand factor, adhesion molecules, etc.) ;Primary end point(s): (hs)-CRP levels | — |
Countries
Austria
Outcome results
None listed