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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

Page last updated: August 20, 2015

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