Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Age: 18-75 years

• Patients with chronic stable angina

• Patients with coronary artery disease or with de novo stent restenosis of native vessels.

• Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.

Exclusion Criteria:

• Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).

• Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.

• Altered basal level of transaminase or CPK.

• Patient with history of hepatitis-acute/chronic.

• Patients already receiving high-dose statins.

• Contraindications to antiplatelet therapy.

• Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.).

• Patients with anemia (haemoglobin <8.5 mg/dl), leukocytosis (WBC> 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 (muscle pain and unexplained repeated)