Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention

IRCCS San Raffaele146 enrolled

Overview

The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.

An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC \> 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Platelet Dysfunction

Interventions

AtorvastatinDRUG

80 mg

RosuvastatinDRUG

40 mg

PlaceboDRUG

no statin loading dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18-75 years * Patients with chronic stable angina * Patients with coronary artery disease or with de novo stent restenosis of native vessels. * Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent. Exclusion Criteria: * Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI). * Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel. * Altered basal level of transaminase or CPK. * Patient with history of hepatitis-acute/chronic. * Patients already receiving high-dose statins. * Contraindications to antiplatelet therapy. * Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.). * Patients with anemia (haemoglobin \<8.5 mg/dl), leukocytosis (WBC\> 12.000 mm3), leukopenia (WBC \<3000 mm3), platelet count \<100.000; hypersplenism. * Patients with malignant disease. * Patients enrolled in other studies not yet completed. * Patients with known allergy / intolerance to statins. * Pregnant women and women who are breastfeeding. * Patients with myopathy (muscle pain and unexplained repeated)

Locations (1)

IRCCS San Raffaele Monte Tabor

Milan, Italy

Outcomes

Primary Outcomes

Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer

Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.

Time frame: Evaluation of platelet reactivity (in terms of AUC) two time points.

Secondary Outcomes

Incidence of periprocedural myocardial infarction

To evaluate if the loading dose of statin prevent the periprocedural myocardial damage measured by CK and CK-MB The measurments will be done once before the procedure and at 6 and 12 hours after.

Time frame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours

Data from ClinicalTrials.gov

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