Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity

Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity

The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay.

This is a prospective, randomized, open-label, control-active trial performed in elective patients candidates to coronary drug eluting stent implantation who presented high-on-treatment platelet reactivity, immediately before coronary intervention (PCI). All patients are treated with aspirin (100 mg/day) and standard-dose clopidogrel (600 mg as loading dose and 75 mg daily as maintenance dose)for at least 7 days before PCI. Platelet function is assessed by the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA). Patients are eligible to be enrolled if they have high-on-treatment reactivity defined as P2Y12 reaction units (PRU) >= 230, immediately before PCI. After PCI, patients are randomized to receive high-dose clopidogrel (150 mg daily) or high-dose atorvastatin (80mg/day) + high-dose clopidogrel (150 mg daily). Study visits and platelet function testing with the VerifyNow P2Y12 test are conducted at 7 and 30 days after randomization.

Inclusion Criteria:

• Stable angina
• candidates to drug eluting stent implantation
• High on-treatment platelet reactivity according to a point-of-care platelet function test

Exclusion Criteria:

• chronic therapy with statins
• inability to provide informed consent
• intolerance to statins
• acute or chronic liver failure or ALT > 2 times ULN
• known myopathy
• CKD stage IV or dialysis treatment
• pregnancy or breast-feeding
• malignancy