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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Anti-Inflammatory Agents; Clopidogrel; Prasugrel Hydrochloride

Criteria

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