Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Information source: University of Cologne
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome; Unstable Angina
Intervention: Prasugrel (Drug); Clopidogrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Cologne Official(s) and/or principal investigator(s): Tanja Rudolph, MD, Principal Investigator, Affiliation: University Hospital of Cologne
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.
Clinical Details
Official title: Vasoactive and Anti-inflammatory Effects of Prasugrel in 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
Primary outcome: Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Cardiology, University Hospital of Cologne, Cologne 50937, Germany
Additional Information
Starting date: October 2014
Last updated: June 10, 2015
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