Trials / Completed
CompletedNCT01774838
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- University of Cologne · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prasugrel | 3 months treatment |
| DRUG | Clopidogrel | 3 months treatment |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2013-01-24
- Last updated
- 2015-06-11
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01774838. Inclusion in this directory is not an endorsement.