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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774838
• Other study ID #: Uni-Koeln-1649
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2013
• Last updated: June 10, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Federal Institute for Drugs and Medicinal Devices : 'Germany'
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Syndrome
• Unstable Angina

Intervention

Drug:
• Prasugrel
3 months treatment
• Clopidogrel
3 months treatment

Locations

Country	Name	City	State
Germany	Cardiology, University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and after 3 months	No