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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stable Angina

Intervention / Treatment
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* Drug: atorvastatin and clopidogrel
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin-Clopidogrel group<br>Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day | Drug: atorvastatin and clopidogrel<br>* Atorvastatin 80 mg daily + clopidogrel 150 mg daily<br>|
| Active Comparator: Clopidogrel group<br>Patients who receive clopidogrel 150 mg daily | Drug: Clopidogrel<br>* Clopidogrel 150 mg daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in on-treatment platelet reactivity at 7 and 30 days | Pharmacodynamic analysis of the randomized groups includes a) assessment of the absolute level of on-treatment reactivity, b) change in on-treatment reactivity, c) rate of high on-treatment reactivity at 7 and 30 days. The platelet reactivity is measured with the VerifyNow P2Y12 test (Accumetrics, SanDiego, CA). | pre-PCI, 7 days and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, Statins, Platelet reactivity, Point-of-care platelet function test