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

NCT01774838 | Completed Phase 3

• 1 other identifier: Uni-Koeln-1649
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Unstable Angina

Outcome Measures

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.

  baseline and after 3 months

Study Arms (2)

Prasugrel

EXPERIMENTAL

3 months treatment with 10 mg prasugrel

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

3 months treatment with clopidogrel 75 mg

Drug: Clopidogrel

Interventions

Prasugrel DRUG

3 months treatment

Also known as: Efient

Prasugrel

Clopidogrel DRUG

3 months treatment

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Cardiology, University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tanja Rudolph, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 24, 2013
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

DE (1)