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

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