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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin-Clopidogrel group | Experimental | Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day |
|
| Clopidogrel group | Active Comparator | Patients who receive clopidogrel 150 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin and clopidogrel | Drug | Atorvastatin 80 mg daily + clopidogrel 150 mg daily |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Leoncini, MD | Ospedale Misericordia e Dolce, Prato | Principal Investigator |
| Anna Toso, MD | Ospedale Misericordia e Dolce, Prato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Ospedale Misericordia e Dolce | Prato | 59100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23428009 | Derived | Leoncini M, Toso A, Maioli M, Angiolillo DJ, Giusti B, Marcucci R, Abbate R, Bellandi F. High-dose atorvastatin on the pharmacodynamic effects of double-dose clopidogrel in patients undergoing percutaneous coronary interventions: The ACHIDO (Atorvastatin and Clopidogrel HIgh DOse in stable patients with residual high platelet activity) study. JACC Cardiovasc Interv. 2013 Feb;6(2):169-79. doi: 10.1016/j.jcin.2012.09.013. |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clopidogrel | Drug | Clopidogrel 150 mg daily |
|
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |