Parossistic Atrial Fibrillation according to the European Socierty of Cardiology (ESC)criteria MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: ATORVASTATIN CALCIUM
CAS Number: 134523-03-8
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type
Sponsors
FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patient between 18 and 75 years of age 2) patient able to understand the study aims and methods, to sign the informed consents relative to the part of the study he is willing to participate 3) patient showing the medical conditions that make a cardioversion procedure mandatory 4) patient whose clinical conditions allow to delay the cardioversion procedure for the time required to enroll the patients in the study (stable patient, that is not feeling extreme pain or anxiety for the condition related to the current episode of atrial fibrillation) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1) hemodynamically unstable patient or bearing comorbidities precluding the possibility to complete the procedures of the study. 2) patient with diagnosis of class III-IV heart failure according to the NYHA classification 3) patients assuming chronically a statin at maximum dosage. 4) patient without hystory of statin intollerance characterized by: statin related myalgia and/or increase of specific enzymes elevation (CK > 2xULN; AST or ALT > 3x ULN) 5) patient assuming oral anticoagulant therapy 6) patient with affections determining intestinal malabsorption as: gastro-ileal by pass, gastric banding, other causes 7) patient with chronic kidney disease stage IV or more according to the NFK classification (calculated Glomerular filtrate rate < 30 ml/min) 8) patient with altered consciousness level, and/or a mental disease not adequately controlled by drug therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1)the chance of a plasma biomarker to predict a successful pharmacological cardioversion. 2)The chance of a plasma biomarker to predict a reduction of the pharmacological cardioversion time 3) the chance that a single dose of rosuvatatin 40 mg might increase the successful pharmacological cardioversion rate 4) the chance that a single dose of rosuvatatin 40 mg might reduce of the pharmacological cardioversion time;Secondary Objective: 1) the chance of a biomarker to predict the probability to maintain a sinus heart rhythm after 1 year since the pharmacological cardioversion. 1) the chance that a single dose of rosuvatatin 40 mg might increase the probability to maintain a sinus heart rhythm after 1 year since the pharmacological cardioversion.;Primary end point(s): 1) successful pharmacological cardioversion rate (number of subjects that recovered their sinus rhythm after the cardioversion procedure / number of subjects subjected to the procedure) 2) the time occurred to recover the normal sinus heart rhythm during a pharmacological cardioversion procedure (the interval time between the start of the procedure and time in which the sinus rhythm is virtually recovered);Timepoint(s) of evaluation of this end point: This end point will be collected in the time interval required to consider the procedure unsuccessful according to the standard clinical procedures, so that the physican is allowed to proceed to alternative protocols (electrical cardioversion, other). This interval is set to 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): proportion of patients that are still maintaining their sinus hearth rhythm after: i) 6 months since the pharmacological cardioversion procedure ii) 12 months since the pharmacological cardioversion procedure;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactClinical Trial Office
Fondazione Istituto San Raffaele G. Giglio di Cefalu'
Outcome results
None listed