Original Research – Clinical Trial Design
Efficacy and Safety of Clopidogrel 600 mg Administered Pre-Hospitally to Improve Primary Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction (CIPAMI): Study Rationale and DesignZeymer U.a · Arntz H.-R.b · Darius H.c · Huber K.d · Senges J.a
aHerzzentrum Ludwigshafen und Institut für Herzinfarktforschung, Ludwigshafen, bMedizinische Klinik II, Kardiologie und Pulmonologie, Charité Campus Benjamin Franklin, and cVivantes Klinikum Berlin-Neukölln, Klinik für Innere Medizin, Kardiologie, Berlin, Germany; dWilhelminenspital, III. Medical Department, Internal Medicine, Vienna, Austria
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Article / Publication Details
Clopidogrel, in combination with acetylsalicylic acid, has become a mainstay of the pharmacological therapy for patients with acute coronary syndromes, especially in those undergoing percutaneous coronary interventions (PCI). While a series of studies has shown that pre-treatment with a loading dose of clopidogrel 300 or 600 mg prior to PCI is effective in reducing cardiovascular complications, the optimal dose and timing in various patient groups is still unclear. The primary objective of the present randomized, open-label Clopidogrel to Improve Primary percutaneous coronary Intervention in Acute Myocardial Infarction (CIPAMI) study is to evaluate the efficacy and the safety of a 600 mg loading dose of clopidogrel in addition to standard acetylsalicylic acid/heparin treatment in the pre-hospital setting in 654 patients with acute ST elevation myocardial infarction scheduled for primary PCI. The primary efficacy endpoint is the TIMI 2/3 patency of the infarct-related artery immediately prior to PCI. The rationale, design and methods of this study are described.
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