Clinical trial NCT01774838: Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Official title: Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Unstable Angina
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
timeFrame: baseline and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Cardiology, University Hospital of Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Tanja Rudolph, MD
role: PRINCIPAL_INVESTIGATOR
References: