Stable Angina
Conditions
Keywords
Clopidogrel, Statins, Platelet reactivity, Point-of-care platelet function test
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.
Interventions
Atorvastatin 80 mg daily + clopidogrel 150 mg daily
DRUGClopidogrel
Clopidogrel 150 mg daily
Sponsors
Ospedale Misericordia e Dolce
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in on-treatment platelet reactivity at 7 and 30 days | pre-PCI, 7 days 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). |
Countries
Italy
Outcome results
None listed