Acute Coronary Syndrome, Unstable Angina
Conditions
Brief 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)
Interventions
DRUGPrasugrel
3 months treatment
DRUGClopidogrel
3 months treatment
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer | 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. |
Countries
Germany
Outcome results
None listed