Clinical trial NCT01335048: Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
Official title: Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina
Keywords: Clopidogrel
Statins
Platelet reactivity
Point-of-care platelet function test
Lead sponsor: Ospedale Misericordia e Dolce
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in on-treatment platelet reactivity at 7 and 30 days
timeFrame: pre-PCI, 7 days and 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Cardiology Department, Ospedale Misericordia e Dolce
Study officials:
affiliation: Ospedale Misericordia e Dolce, Prato
name: Mario Leoncini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Misericordia e Dolce, Prato
name: Anna Toso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.