Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Acute Coronary Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome|
- Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer [ Time Frame: baseline and after 3 months ] [ Designated as safety issue: No ]The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
|Study Start Date:||October 2014|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
3 months treatment with 10 mg prasugrel
3 months treatment
Other Name: Efient
Active Comparator: Clopidogrel
3 months treatment with clopidogrel 75 mg
3 months treatment
Other Name: Plavix
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.
Primary Endpoint Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774838
|Cardiology, University Hospital of Cologne|
|Cologne, Germany, 50937|
|Principal Investigator:||Tanja Rudolph, MD||University Hospital of Cologne|