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

U

University of Cologne

Status and phase

Completed
Phase 3

Conditions

Unstable Angina
Acute Coronary Syndrome

Treatments

Drug: Clopidogrel
Drug: Prasugrel

Study type

Interventional

Funder types

Other

Identifiers

NCT01774838
Uni-Koeln-1649

Details and patient eligibility

About

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.

Full 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)

Enrollment

49 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

49 participants in 2 patient groups

Prasugrel
Experimental group
Description:
3 months treatment with 10 mg prasugrel
Treatment:
Drug: Prasugrel
Clopidogrel
Active Comparator group
Description:
3 months treatment with clopidogrel 75 mg
Treatment:
Drug: Clopidogrel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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