Atorvastatin at high dosage before coronary stent surgery: effect on peri-procedure miocardic stroke . - ND
- Conditions
- elective PCI in de novo coronaric lesionsMedDRA version: 6.1Level: SOCClassification code 10047065
- Registration Number
- EUCTR2007-005056-16-IT
- Lead Sponsor
- OSPEDALE S. RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
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
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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method