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CompletedNCT01774838Updated Jun 11, 2015

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

A Phase 3 interventional study of Prasugrel and Clopidogrel in Acute Coronary Syndrome and Unstable Angina, sponsored by University of Cologne. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-06-11.

Sponsored by University of Cologne · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Acute Coronary Syndrome
  • Unstable Angina
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 49 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute coronary syndrome, unstable angina
  • planned percutaneous coronary intervention
  • Written informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Prasugrel

    3 months treatment with 10 mg prasugrel

    Drug: Prasugrel

  • Active comparator
    Clopidogrel

    3 months treatment with clopidogrel 75 mg

    Drug: Clopidogrel

Interventions

  • DrugPrasugrel

    3 months treatment

    Also known as: Efient

  • DrugClopidogrel

    3 months treatment

    Also known as: Plavix

06

What researchers measure

Primary outcomes

  1. Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer

    The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.

    Time frame: baseline and after 3 months

07

Study locations

1 site
  • Cardiology, University Hospital of Cologne
    Cologne, 50937, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01774838
Lead sponsor
University of Cologne
Responsible party
Tanja Rudolph (Consultant, University of Cologne) — Principal investigator
First posted
Jan 24, 2013
Start date
Oct 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jun 11, 2015

Study contacts

Tanja Rudolph, MD
principal investigator · University Hospital of Cologne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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