Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
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|ClinicalTrials.gov Identifier: NCT01774838|
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : June 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Unstable Angina||Drug: Prasugrel Drug: Clopidogrel||Phase 3|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
- 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 ]The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774838
|Cardiology, University Hospital of Cologne|
|Cologne, Germany, 50937|
|Principal Investigator:||Tanja Rudolph, MD||University Hospital of Cologne|