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| Sponsor: | Stiftung Institut fuer Herzinfarktforschung |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Sanofi-Aventis |
| Information provided by: | Stiftung Institut fuer Herzinfarktforschung |
| ClinicalTrials.gov Identifier: | NCT00372216 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: Clopidogrel (Iscover/Plavix) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction |
| Estimated Enrollment: | 654 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)
|
Drug: Clopidogrel (Iscover/Plavix)
Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
|
|
2: No Intervention
Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Uwe Zeymer, MD | +49 621-503-0 | ZeymerU@klilu.de |
| Germany | |
| DRK-Kliniken Westend | Recruiting |
| Berlin, Germany, 14050 | |
| Contact: Ralph Schoeller, MD | |
| Principal Investigator: Ralph Schoeller, MD | |
| Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus | Recruiting |
| Berlin, Germany, 10365 | |
| Contact: Sven Tessin, MD | |
| Principal Investigator: Sven Tessin, MD | |
| Universitaetsklinikum Benjamin Franklin | Recruiting |
| Berlin, Germany, 12200 | |
| Contact: Hans-Richard Arntz, MD | |
| Principal Investigator: Hans-Richard Arntz, MD | |
| Vivantes Klinikum Neukoelln | Recruiting |
| Berlin, Germany, 12351 | |
| Contact: Harald Darius, MD | |
| Principal Investigator: Harald Darius, MD | |
| Maria Heimsuchung / Caritas-Klinik Pankow | Recruiting |
| Berlin, Germany, 13187 | |
| Contact: Heiko Lehmann, MD | |
| Principal Investigator: Heiko Lehmann, MD | |
| Staedtisches Klinikum | Recruiting |
| Brandenburg, Germany, 14770 | |
| Contact: Michael Oeff, MD | |
| Principal Investigator: Michael Oeff, MD | |
| Germany, Baden-Wuerttemberg | |
| Universitaetsklinikum Mannheim | Recruiting |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| Contact: Juergen Meinhardt, MD | |
| Principal Investigator: Juergen Meinhardt, MD | |
| Germany, Brandenburg | |
| KMG-Kliniken AG / Klinikum Wittstock | Recruiting |
| Wittstock, Brandenburg, Germany, 16909 | |
| Contact: Volker Hitz, MD | |
| Principal Investigator: Volker Hitz, MD | |
| Germany, Hessen | |
| Klinikum der Johann-Wolfgang-Goethe Universitaet | Recruiting |
| Frankfurt, Hessen, Germany, 60590 | |
| Contact: Andreas Zeiher, MD | |
| Principal Investigator: Andreas Zeiher, MD | |
| St. Vincenz-Krankenhaus | Recruiting |
| Limburg, Hessen, Germany, 65549 | |
| Contact: Joerg Kreuzer, MD | |
| Principal Investigator: Joerg Kreuzer, MD | |
| Kerckhoff Klinik | Not yet recruiting |
| Bad Nauheim, Hessen, Germany, 61231 | |
| Contact: Thorsten Dill, MD | |
| Principal Investigator: Thorsten Dill, MD | |
| Universitaetsklinikum Giessen | Not yet recruiting |
| Giessen, Hessen, Germany, 35392 | |
| Contact: Till Spiegl, MD | |
| Principal Investigator: Ali Erdogan, MD | |
| Kreiskrankenhaus Bergstrasse | Not yet recruiting |
| Heppenheim, Hessen, Germany, 64646 | |
| Contact: Wolfgang Auch-Schwelk, MD | |
| Principal Investigator: Wolfgang Auch-Schwelk, MD | |
| Klinikum Darmstadt | Not yet recruiting |
| Darmstadt, Hessen, Germany, 64283 | |
| Contact: Gerald Werner, MD | |
| Principal Investigator: Gerald Werner, MD | |
| Germany, Niedersachsen | |
| Medizinische Hochschule | Not yet recruiting |
| Hannover, Niedersachsen, Germany, 30625 | |
| Contact: Bernhard Schieffer, MD | |
| Principal Investigator: Bernhard Schieffer, MD | |
| Evangelisches Krankenhaus | Not yet recruiting |
| Holzminden, Niedersachsen, Germany, 37603 | |
| Contact: Christian Beythien, MD | |
| Principal Investigator: Christian Beythien, MD | |
| Städtisches Klinikum | Not yet recruiting |
| Lüneburg, Niedersachsen, Germany, 21339 | |
| Contact: Wolfram Kupper, MD | |
| Principal Investigator: Wolfram Kupper, MD | |
| Germany, Nordrhein-Westfalen | |
| Klinikum Leverkusen | Recruiting |
| Leverkusen, Nordrhein-Westfalen, Germany, 51375 | |
| Contact: Peter Schwimmbeck, MD | |
| Principal Investigator: Peter Schwimmbeck, MD | |
| Germany, Rheinland-Pfalz | |
| Klinikum der Stadt Ludwigshafen, Med. Klinik B | Recruiting |
| Ludwigshafen, Rheinland-Pfalz, Germany, 67063 | |
| Contact: Bernd Mark, MD +49 621-503-0 MarkB@klilu.de | |
| Principal Investigator: Bernd Mark, MD | |
| Sub-Investigator: Joerg Friedrich, MD | |
| Sub-Investigator: Elke Fromm, MD | |
| Germany, Saarland | |
| Klinikum Saarbruecken | Recruiting |
| Saarbruecken, Saarland, Germany, 66119 | |
| Contact: Heiner Krieter, MD | |
| Principal Investigator: Heiner Krieter, MD | |
| Germany, Sachsen | |
| Universitaet Leipzig - Herzzentrum | Recruiting |
| Leipzig, Sachsen, Germany, 04289 | |
| Contact: Holger Thiele, MD | |
| Principal Investigator: Holger Thiele, MD | |
| Principal Investigator: | Uwe Zeymer, MD | Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany |
More Information
| Responsible Party: | Stiftung Institut fuer Herzinfarktforschung Ludwigshafen ( Prof. Dr. Jochen Senges ) |
| Study ID Numbers: | CIPAMI |
| Study First Received: | September 4, 2006 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00372216 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
myocardial infarction Clopidogrel primary PCI TIMI-flow STEMI within 6 hrs. |
|
Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases Ischemia Pharmacologic Actions Necrosis |
Pathologic Processes Clopidogrel Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Infarction Myocardial Infarction |
