Acute Coronary Syndrome Clinical Trial
Official title:
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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