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

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ClinicalTrials.gov Identifier: NCT01774838
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Tanja Rudolph, University of Cologne

Tracking Information
First Submitted Date  ICMJE January 16, 2013
First Posted Date  ICMJE January 24, 2013
Last Update Posted Date June 11, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
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 ]
The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Official Title  ICMJE Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Unstable Angina
Intervention  ICMJE
  • Drug: Prasugrel
    3 months treatment
    Other Name: Efient
  • Drug: Clopidogrel
    3 months treatment
    Other Name: Plavix
Study Arms  ICMJE
  • Experimental: Prasugrel
    3 months treatment with 10 mg prasugrel
    Intervention: Drug: Prasugrel
  • Active Comparator: Clopidogrel
    3 months treatment with clopidogrel 75 mg
    Intervention: Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2013)
54
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774838
Other Study ID Numbers  ICMJE Uni-Koeln-1649
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tanja Rudolph, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tanja Rudolph, MD University Hospital of Cologne
PRS Account University of Cologne
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP