vasoactive and anti-inflammatory effects of prasugrel in acute coronary syndrome

Conditions: Acute Coronary Syndrome; Unstable Angina

Summary: to test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome endothelial function -as a surrogate parameter of no bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.

trial objectives to test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome, endothelial function -as a surrogate parameter of no bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina. trial design single center, double blind, double-dummy, randomized, parallel trial. endpoints primary endpoint assessment of endothelial function (fmd) via high-resolution ultrasound (sonoline g50, 12 mhz linear array transducer, siemens, germany) by experienced sonographer. secondary endpoints * non-invasive assessment of microvascular perfusion and oxygen saturation by laser doppler perfusion imaging and tissue spectrometry (o2c, lea medizintechnik, giessen, germany) * determination of leukocyte activity: plasma mpo levels (elisa), plasma elastase levels (elisa) * assessment of platelet activity: plasma levels of scd40 ligand (elisa), rantes (elisa) * measurement of different oxidative stress markers: hscrp (elisa), cd40 ligand (elisa), carbonylated proteins (elisa), urinary 8-iso-pgf2α (gas chromatography mass spectrometry) * determination of platelet-leukocyte aggregates by fluorescent activated cell sorter (facs) * assessment of platelet function (pada-test)

Eligibility criteria:
inclusion criteria: * acute coronary syndrome, unstable angina * planned percutaneous coronary intervention * written informed consent exclusion criteria: * - age \< 18 years or ≥75 years * body weight \< 60 kg * stemi, nstemi * cardiogenic shock at the time of randomization * refractory ventricular arrhythmias * congestive heart failure (nyha iv) * increased risk of bleeding * active internal bleeding or history of hemorrhagic diathesis * history of tia, ischemic or hemorrhagic stroke * intracranial neoplasm, aneurysm and arteriovenous malformation * inr \> 1.5 at screening * platelets \< 100,000/ml * anemia (hb \< 10 g/dl) at screening * one or more doses of a thienopyridine 5 d or less before pci * oral anticoagulation which cannot be safely discontinued for the duration of the study * one or more doses of a thienopyridine 5 d or less before pci * treatment within the last 30 d with an investigational drug or are presently enrolled in another drug or device study * women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding * concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period * known severe hepatic dysfunction * any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence * intolerance of or allergy to aspirin, ticlopidine, or clopidogrel