Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Tanja Rudolph, University of Cologne
ClinicalTrials.gov Identifier:
NCT01774838
First received: January 16, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Unstable Angina
Drug: Prasugrel
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer [ Time Frame: baseline and after 3 months ] [ Designated as safety issue: No ]
    The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.


Estimated Enrollment: 54
Study Start Date: October 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel
3 months treatment with 10 mg prasugrel
Drug: Prasugrel
3 months treatment
Other Name: Efient
Active Comparator: Clopidogrel
3 months treatment with clopidogrel 75 mg
Drug: Clopidogrel
3 months treatment
Other Name: Plavix

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774838

Contacts
Contact: Tanja Rudolph, MD 0049221478323 ext 96 tanja.rudolph@uk-koeln.de
Contact: Stephan Baldus, MD 004922147832511 stephan.baldus@uk-koeln.de

Locations
Germany
Cardiology, University Hospital of Cologne Recruiting
Cologne, Germany, 50937
Contact: Tanja Rudolph, MD    0049221478323 ext 96    tanja.rudolph@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Tanja Rudolph, MD University Hospital of Cologne
  More Information

No publications provided

Responsible Party: Tanja Rudolph, Consultant, University of Cologne
ClinicalTrials.gov Identifier: NCT01774838     History of Changes
Other Study ID Numbers: Uni-Koeln-1649
Study First Received: January 16, 2013
Last Updated: October 10, 2014
Health Authority: Federal Institute for Drugs and Medicinal Devices : 'Germany'

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Prasugrel
Clopidogrel
Anti-Inflammatory Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on October 19, 2014