Effects of simvastatin in patients after cardioversion (SIPAC) of non valvular atrial fibrillation - The AF Prophylaxis Trial

• Conditions: patients after successful cardioversion of atrial fibrillation

• Registration Number: EUCTR2006-003119-35-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

-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 < 30%
-Severe rhythmological disorders other than AF (WPW-Syndrome, AV block II-III etc)
- Prolonged QT interval (QTc interval of >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 <30 mL/min)
-Creatinine level of more than 2.5 mg per deciliter
-Known severe hepatic disorders or persistent elevation of liver enzymes of more than two times the upper limit of normal
-Unexplained elevation in the creatine kinase level more than three times the upper limit of normal
-Women with child bearing potential
-Drug addiction, alcohol abuse
-Anaemia (haemoglobin <100 g/L or platelet count <100x109/L)
-Abnormal electrolytes despite adequate therapy (especially potassium <3.5 or >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)

Study & Design

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