Viewing Study NCT01090336



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Last Modification Date: 2024-10-26 @ 10:17 AM
Study NCT ID: NCT01090336
Status: UNKNOWN
Last Update Posted: 2011-04-18
First Post: 2010-03-16

Brief Title: Prasugrel Versus Clopidogrel in Acute Coronary Syndrome ACS Undergoing Percutaneous Coronary Intervention PCI
Sponsor: Heidelberg University
Organization: Heidelberg University

Study Overview

Official Title: Prevalence of Inadequate Platelet Inhibition After Oral Loading With PrasugrelClopidogrel in Patients With an Acute Coronary Syndrome Undergoing Early PCI
Status: UNKNOWN
Status Verified Date: 2010-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Both prasugrel and clopidogrel are prescribed drugs which compete as platelet inhibitors in patients with acute coronary syndrome ACS Whether rates of drug resistancehyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing early PCI remains at present unknown

Study designstudy population This trial is a prospective open-label single centre observational trial Patients receive either prasugrel 60mg or clopidogrel 600mg at the discretion of the attending cardiologist Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well The study population includes 80 subjects with moderate to high-risk ACS ie patients with unstable angina UA and non-ST-segment elevation MI NSTEMI and TIMI risk score of 3 or higher within 72 hours after onset of symptoms In all patients early PCI is planned

Study objectiveendpointmethods The primary objective of this trial is to evaluate whether rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early PCI

The primary endpoint is the rate of drug resistance at time of index intervention Optical and impedance aggregometry using ADP 5 and 20 μM and collagen 1 μgml as platelet agonists is used to measure platelet aggregation Addition of the specific antagonists aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and pharmacokinetic drug resistance

Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT TnT hs during the days following the index event reflecting earlier more effective and more consistent inhibition of platelet function

Tertiary endpoint is the composite clinical endpoint of cardiovascular death nonfatal MI or stroke and urgent target vessel revascularization during hospitalization and after 6 and 12 months

Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12 months including intracranial and life-threatening bleeding
Detailed Description: look above

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
S-2352009 OTHER Ethics committee of the University of Heidelberg None