Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium, which can be achieved by either thrombolytic therapy or primary PCI. Primary PCI is facilitated if the flow in the target vessel is restored prior to the intervention. In addition the results of recent trials hint that clinical outcome is improved by a patent infarct-vessel before primary PCI. The CIPAMI-study analyses the effect of an early administration of Clopidogrel on the flow-rates in subjects who suffered an acute myocardial infarction. For this purpose they are divided into two groups, both receiving standard baseline treatment. The subjects of one group additionally receive 600mg of Clopidogrel, as early as possible, while the subjects in the second group receive standard therapy. In the second group Clopidogrel is not allowed before initial angiography. In both groups the flow-rates before and after PCI are analysed and compared in order to evaluate the efficacy, feasibility, and safety of the administration of a high loading dose Clopidogrel in the very early phase of STEMI in the prehospital setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
337
Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
Universitaetsklinikum Innsbruck
Innsbruck, Austria
Hanusch-Krankenhaus
Vienna, Austria
Wilhelminenspital
Vienna, Austria
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, Germany
Staedtisches Klinikum
Brandenburg an der Havel, Brandenburg, Germany
KMG-Kliniken AG / Klinikum Wittstock
Wittstock, Brandenburg, Germany
Kerckhoff Klinik
Bad Nauheim, Hesse, Germany
Klinikum Darmstadt
Darmstadt, Hesse, Germany
Klinikum der Johann-Wolfgang-Goethe Universitaet
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Giessen
Giessen, Hesse, Germany
...and 15 more locations
TIMI 2/3 patency of the infarct-related artery immediately prior to PCI
Time frame: Assessment at primary PCI, asap after inclusion of the subject
TIMI 3 patency before PCI
Time frame: Assessment before primary PCI, asap after inclusion of the subject
TIMI 3 patency after PCI
Time frame: Assessment at primary PCI, asap after inclusion of the subject
ST resolution immediately before angiography and 60-90 minutes after PCI
Time frame: Assessment immediately before angiography until 90 minutes after PCI
Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge
Time frame: Starting with inclusion of the subject until day 7
Stroke (hemorrhagic, non-hemorrhagic)
Time frame: Starting with inclusion of the subject until day 7
Severe bleeding complications according to the TIMI classification
Time frame: Starting with inclusion of the subject until day 7
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