elective PCI in de novo coronaric lesions MedDRA version: 6.1 Level: SOC Classification code 10047065
Conditions
Interventions
Trade Name: TORVAST
Pharmaceutical Form: Tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the pla
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)age > or equal 18 yeras old; 2) no ongoing treatment with statine 3)new stenosis on native vassel 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: 1) pregnancy; 2) acute pulmonary edema ;3)acute miocardic stroke and/or acute coronaric syndrome; 4) high values of cardiac enzymes; 5) recent (2 days or more) acute miocardic stroke and/or acute coronaric syndrome; 6) patients enrolled in omgoing studies; 7) ongoing statine system; 8) chronic renal insufficiency in dialisis; 9) intollerance history to statine, ticopidina or clopidogrel; 10) ongoing treatment withglicoproteina IIbIIIa inhibitors;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: efficacy evaluation of acute administration of Atorvastatin at high dose (80 mg) the day before surgery in prevention of peri-procedure stroke.;Secondary Objective: efficacy evaluation of acute administration of Atorvastatin at high dose (80 mg) the day before surgery in prevention of peri-procedure stroke.;Primary end point(s): efficacy evaluation of acute administration of Atorvastatin at high dose (80 mg) the day before surgery in prevention of peri-procedure stroke. | — |
Countries
Italy
Outcome results
None listed