In patients with suspected stable CAD candidates to PCI MedDRA version: 12.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Rosuvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route o
Sponsors
CARDIOLOGIA UNIVERSITARIA - OSPEDALE CLINICIZZATO SS. ANNUNZIATA - VIA DEI VESTINI - 66013 CHIETI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria will be the presence of suspected CAD for which an indication to PCI is given. This study will therefore include both patients with stable CAD, and stable post-acute coronary syndromes (ACS), both with ST-segment elevation (STEMI) and without ST-segment elevation (NSTE-ACS) patients, provided that markers of myocardial necrosis (CK-MB, troponins) are stabilized (i.e., with variations =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will be: o any previously known increase in liver enzymes (AST, ALT) ascribed to liver dysfunction at baseline; o history of liver toxicity or myopathy on previous treatment with statins; o left ventricular ejection fraction 2 mg/dL at baseline; o pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (a) documenting whether the immediate pre-procedural administration of rosuvastatin at a high dosage may reduce the extent of peri-procedural MI compared with placebo on the background of the best current medical therapy;;Secondary Objective: 1.Characterizing the relevance of HMG-CoA reductase inhibition (vs largely HMG-CoA reductase-independent cholesterol lowering) in this phenomenon; 2.Providing a mechanistic explanation for such effects, investigating the role of HO-1 in the context of peri-PCI myocardial damage.;Primary end point(s): Primary outcomes will be i) any post-procedural increase of any measured marker of myocardial injury (CK-MB, troponin I or troponin T) above upper normal limits, measured as the sum of the values at the post-PCI determinations at 8, 24 and 48 h; ii) peak values of CK-MB, troponin I or troponin T after intervention; iii) the occurrence of myocardial infarction, defined as a post-procedural increase of CK-MB >3 times above the upper normal limit, according to the dichotomic definition of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, at 48 h. | — |
Countries
Italy
Outcome results
None listed