Clinical trial NCT01526460: Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention
Official title: Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Platelet Dysfunction
Keywords: Platelet
Atorvastatin
Rosuvastatin
Multiplate
reactivity
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: 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 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer
timeFrame: Evaluation of platelet reactivity (in terms of AUC) two time points.
Secondary outcomes:
measure: Incidence of periprocedural myocardial infarction
timeFrame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Monte Tabor
Study officials:
affiliation: IRCCS San Raffaele Monte Tabor
name: Antonio Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References: