Patients with Acute coronary syndrome without up-leveling of ST line. MedDRA version: 9.1 Level: SOC Classification code 10007541 MedDRA version: 9.1 Level: HLT Classification code 10011085
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical Form: Tablet
INN or Proposed INN:
Sponsors
AZIENDA SANITARIA LOCALE DI BARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included patients aged from 18th to 80anni diagnosed with NSTE-SCA values and HS-PCR> 2 mg / dl. 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: Will be excluded all patients who have one of the following medical conditions: Diabetes mellitus Smokers and former smokers from ≤ 10 aa note dyslipidemia (LDL cholesterol ≥ 160 mg / dL or Trigliceridemia ≥ 150 mg / dl) and / or drug treatment known coronary artery disease Pregnancy or breastfeeding Chronic renal insufficiency (creatinine> 2.2 mg / dl or GFR-glomerular filtration-calculated with the formula of Cockroft and Gault, 30ml/min) Hepatic impairment Infectious Diseases and / or acute inflammatory conditions in place and / or chronic active or malignant neoplasia in history innate or acquired immune deficiency cerca
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare the performance of hs-PCR in patients at first diagnosis of SCA without up-levelling tract ST (NSTE SCA in these subjects, according to the guidelines of the European Society of Cardiology, the statin is given within 4 days after acute event. The patients are dealed with Atorvastatin 80 mg / day or Rosuvastatin 20 mg / day, in order to identify whether the two statins are of similar efficacy, or one of the two is higher.;Primary end point(s): Evaluation of the effectiveness of Rosuvastatin 20 mg lowering of the values of PCR and greater stabilization of atherosclerotic plaques compared to Atorvastatin 80 mg in patients with SCA-NTSE;Secondary Objective: Monitoring the PCR (determined by ultra-method), an indicator of inflammation behind SCA, a cofactor of destabilization of plaque in patients candidates for PTCA. The evaluation will be performed in PTCA patients, from the time of diagnosis to the procedure Coronary Angioplasty (PTCA) and a short time from it. The cardio-vascular events in the time will be assessed through clinical follow-up of patients enrolled. | — |
Countries
Italy
Outcome results
None listed