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

San Donato Group (GSD)

Status and phase: Completed; Phase 2

Conditions: Platelet Dysfunction

Treatments: Drug: Rosuvastatin; Drug: Placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01526460

STATIPLAT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 3 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

Atorvastatin 80 mg

Treatment:

Drug: Atorvastatin

Rosuvastatin

Active Comparator group

Description:

Rosuvastatin 40 mg

Treatment:

Drug: Rosuvastatin

No statin loading dose

Placebo Comparator group

Description:

No statin loading dose

Treatment:

Drug: Placebo