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Efficacy and safety of a high loading dose of clopidogrel administered prehospitally to improve primary percutaneous coronary intervention in acute myocardial infarction: the randomized CIPAMI trial

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Abstract

Objectives

To compare a loading dose of 600 mg clopidogrel given in the prehospital phase versus clopidogrel administered only after the diagnostic angiogram in patients with STEMI scheduled for primary PCI.

Background

The optimal time and dose for the initiation of clopidogrel therapy in patients with STEMI scheduled for primary PCI has not been studied in prospective randomized trials.

Methods

The primary efficacy endpoint was the TIMI 2/3 patency of the infarct-related artery in the diagnostic angiography immediately prior to PCI.

Results

We randomized 337 patients to prehospital (n = 166) loading dose versus standard therapy (n = 171). The time interval between initiation of clopidogrel therapy and diagnostic angiography was 47 min. TIMI 2/3 patency before PCI was not different between the groups (49.3 vs. 45.1%, P = 0.5). We observed a trend towards a reduction of the combined endpoint death, re-infarction, and urgent target vessel revascularization in the prehospital-treated patients (3.0 vs. 7.0%, P = 0.09), this difference was significant if patients were classified as treated (4/161 vs. 13/174; 2.5 vs. 7.5%, P < 0.05). There was no difference in TIMI major bleeding complications (9.1 vs. 8.2%, P = 0.8).

Conclusions

Early inhibition of the platelet ADP-receptor with a high loading dose of 600 mg clopidogrel given in the prehospital phase in patients with STEMI scheduled for primary PCI is safe, did not increase pre-PCI patency of the infarct vessel, but was associated with a trend towards a reduction in clinical events.

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Acknowledgments

The study has been supported by an unrestricted grant of Bristol Myers Squibb (BMS). Munich, and Sanofi-Aventis, Berlin, Germany.

Study chairmen: Uwe Zeymer; Steering committee: Hans-Richard Arntz, Harald Darius, Kurt Huber. Angiographic Core laboratory: Walter Desmet, University of Leuven, Belgium. ECG Core laboratory: Rolf Schröder, Berlin, Germany. Project leader Institut für Herzinfarktforschung Ludwigshafen, Germany: Frank Diller. Participating Centers appearing in the order of the number of enrolled patients: Charité Campus Benjamin Franklin, Berlin: Hans-Richard Arntz; Herzzentrum Ludwigshafen: Bernd Mark, Uwe Zeymer; Universitätsklinikum Frankfurt: Andreas Zeiher, Stephan Fichtschlerer; Klinikum Darmstadt: Gerald Werner; DRK-Klinikum Westend, Berlin: Ralph Schöller, Dietlind Glöckner; Klinikum Leverkusen: Peter Schwimmbeck, Wolfgang Jansen; Caritas-Klinik Pankow, Berlin: Heiko Lehmann; Kreiskrankenhaus Bergstraße, Heppenheim: Wolfgang Auch-Schwelk, Thomas Schnebelt; Städtisches Klinikum Brandenburg: Michael Oeff, Claudia Sprenger; Universitätsklinikum Rostock: Christoph Nienaber, Hendrik Schneider; Klinikum Lüneburg: Wolfram Kupper; Wilhelminenspital, Wien: Kurt Huber; Klinikum Saarbrücken: Günter Görge; Kerckhoff-Klinik, Bad Nauheim: Thorsten Dill; Sana Klinikum Lichtenberg, Berlin: Sven Tessin; Vivantes Klinikum Neukölln, Berlin: Harald Darius; Universitätsklinikum Innsbruck: Otmar Pachinger; KMG Kliniken/Klinikum Wittstock: Volker Hitz; Universitätsklinikum Gießen: Ali Erdogan; Allgemeines Krankenhaus Celle: Uwe Klotz; Universität Leipzig - Herzzentrum: Holger Thiele; St. Vincenz Krankenhaus, Limburg: Jörg Kreuzer; Hanusch-Krankenhaus, Wien: Georg Gaul; Evangelisches Krankenhaus, Holzminden: Christian Beythien

Author information

Authors and Affiliations

  1. Klinikum Ludwigshafen, Medizinische Klinik B, Ludwigshafen, Germany

    Uwe Zeymer, Bernd Mark & Ralf Zahn

  2. Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg, Bremserstr. 79, 67063, Ludwigshafen am Rhein, Germany

    Uwe Zeymer & Frank Diller

  3. Medizinische Klinik II, Charité Campus Benjamin Franklin, Berlin, Germany

    Hans-Richard Arntz

  4. Universitätsklinikum, Frankfurt/Main, Germany

    Stephan Fichtlscherer

  5. Klinikum Darmstadt, Hessen, Germany

    Gerald Werner

  6. DRK-Klinikum Westend, Berlin, Germany

    Ralph Schöller

  7. Vivantes Klinikum Neukölln, Berlin, Germany

    Harald Darius

  8. Sana Krankenhaus Benrath, Düsseldorf, Germany

    Thorsten Dill

  9. Cardiology and Emergency Medicine, 3rd Medical Department, Wilhelminenspital, Vienna, Austria

    Kurt Huber

Authors
  1. Uwe Zeymer
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  2. Hans-Richard Arntz
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  8. Frank Diller
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  9. Harald Darius
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  11. Kurt Huber
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Correspondence to Uwe Zeymer.

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Zeymer, U., Arntz, HR., Mark, B. et al. Efficacy and safety of a high loading dose of clopidogrel administered prehospitally to improve primary percutaneous coronary intervention in acute myocardial infarction: the randomized CIPAMI trial. Clin Res Cardiol 101, 305–312 (2012). https://doi.org/10.1007/s00392-011-0393-1

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  • DOI: https://doi.org/10.1007/s00392-011-0393-1

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