Prasugrel Versus Clopidogrel in Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
|ClinicalTrials.gov Identifier: NCT01090336|
Recruitment Status : Unknown
Verified March 2010 by Heidelberg University.
Recruitment status was: Recruiting
First Posted : March 19, 2010
Last Update Posted : April 18, 2011
Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug resistance/hyporesponsiveness 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 design/study 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 objective/endpoint/methods: 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 μg/ml) 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.
|Condition or disease|
|Patients With Acute Coronary Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||26 participants|
|Official Title:||Prevalence of Inadequate Platelet Inhibition After Oral Loading With Prasugrel/Clopidogrel in Patients With an Acute Coronary Syndrome Undergoing Early PCI|
|Study Start Date :||August 2009|
|Estimated Study Completion Date :||December 2011|
At the discretion of the attending cardiologist patients are treated with clopidogrel (600mg loading and 75mg daily dose)
At the discretion of the attending cardiologist patients are treated with prasugrel (60mg loading and 10mg daily dose)
- The primary endpoint is the rate of drug resistance at time of index intervention. [ Time Frame: Routinely, platelet aggregation is evaluated ideally daily up to 96 hours after index event. ]Platelet aggregation is determined by light transmission and impedance aggregometry as previoulsy described (Boris T. Ivandic, Philipp Schlick, Peter Staritz, Kerstin Kurz, Hugo A. Katus and Evangelos Giannitsis: Determination of Clopidogrel Resistance by Whole Blood Platelet Aggregometry and Inhibitors of the P2Y12 Receptor; Clinical Chemistry 52: 383-388, 2006)
- Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs). [ Time Frame: Routinely, ideally daily until 96h after index event. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090336
|University of Heidelberg||Recruiting|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Contact: Evangelos Giannitsis, Prof. Dr. +49 (0)6221-56-8611 Evangelos_Giannitsis@med.uni-heidelberg.de|
|Sub-Investigator: Kerstin Kurz, Dr.|
|Principal Investigator:||Evangelos Giannitsis, Prof. Dr.||Department of Cardiology, University of Heidelberg|