ischemic heart disease MedDRA version: 14.1 Level: LLT Classification code 10023024 Term: Ischaemic heart disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: TORVAST*28CPR RIV 80MG PVC-AL
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration number: 80-
Trade Name: CRESTOR*28CPR
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age: 18-75 years -Patients with chronic stable angina -Patients with coronary restenosis de novo or with intrastent restenosi on native vessels. -Patients who are able to understand the significance of this study and adhere all'arruolamento by signing the informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -acute coronary syndromes-moving enzyme (STEMI, NSTEMI). -allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel. -alteration of base-transaminase or CPK -patient with history of acute or chronic hepatitis - patients already receiving high-dose statins. -contraindications to antiplatelet therapy. -patients with acute inflammatory disease and / or chronic (hepatitis, pneumonia, urinary tract, rectum, ulcerative colitis etc...) -patients with anemia (hemoglobin 12,000 mm3), leukopenia (WBC <3000 mm3), platelet count <100,000; hypersplenism. -patients with malignant disease -patients enrolled in other studies not yet completed. -patients with known allergy / intolerance to statins -pregnant women and women who are breastfeeding. -patients with myopathy (unexplained and repeated muscle pain )
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme).;Secondary Objective: Assessing the values of miocardiocitolisi markers (CK-MB, total CK) and CRP levels measured before and after the procedure in the catheterization room.;Primary end point(s): Difference in platelet reactivity measured before and after a single administration of statins at high doses. | — |
Countries
Italy
Outcome results
None listed