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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction |
| Enrollment: | 337 |
| Study Start Date: | October 2006 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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
Other Names:
|
|
No Intervention: 2
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| Austria | |
| Universitaetsklinikum Innsbruck | |
| Innsbruck, Austria, A-6020 | |
| Wilhelminenspital | |
| Wien, Austria, A-1171 | |
| Hanusch-Krankenhaus | |
| Wien, Austria, A-1140 | |
| Germany | |
| Universitaetsklinikum Mannheim | |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| KMG-Kliniken AG / Klinikum Wittstock | |
| Wittstock, Brandenburg, Germany, 16909 | |
| Kerckhoff Klinik | |
| Bad Nauheim, Hessen, Germany, 61231 | |
| Klinikum Darmstadt | |
| Darmstadt, Hessen, Germany, 64283 | |
| Klinikum der Johann-Wolfgang-Goethe Universitaet | |
| Frankfurt, Hessen, Germany, 60590 | |
| Universitaetsklinikum Giessen | |
| Giessen, Hessen, Germany, 35392 | |
| Kreiskrankenhaus Bergstrasse | |
| Heppenheim, Hessen, Germany, 64646 | |
| St. Vincenz-Krankenhaus | |
| Limburg, Hessen, Germany, 65549 | |
| Universitaetsklinikum Rostock | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18057 | |
| Allgemeines Krankenhaus | |
| Celle, Niedersachsen, Germany, 29223 | |
| Evangelisches Krankenhaus | |
| Holzminden, Niedersachsen, Germany, 37603 | |
| Städtisches Klinikum | |
| Lüneburg, Niedersachsen, Germany, 21339 | |
| Klinikum Leverkusen | |
| Leverkusen, Nordrhein-Westfalen, Germany, 51375 | |
| Klinikum der Stadt Ludwigshafen, Med. Klinik B | |
| Ludwigshafen, Rheinland-Pfalz, Germany, 67063 | |
| Klinikum Saarbruecken | |
| Saarbruecken, Saarland, Germany, 66119 | |
| Universitaet Leipzig - Herzzentrum | |
| Leipzig, Sachsen, Germany, 04289 | |
| DRK-Kliniken Westend | |
| Berlin, Germany, 14050 | |
| Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus | |
| Berlin, Germany, 10365 | |
| Maria Heimsuchung / Caritas-Klinik Pankow | |
| Berlin, Germany, 13187 | |
| Universitaetsklinikum Benjamin Franklin | |
| Berlin, Germany, 12200 | |
| Vivantes Klinikum Neukoelln | |
| Berlin, Germany, 12351 | |
| Staedtisches Klinikum | |
| Brandenburg, Germany, 14770 | |
| Principal Investigator: | Uwe Zeymer, MD | Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany |
More Information
| Responsible Party: | Prof. Dr. Jochen Senges, Stiftung Institut fuer Herzinfarktforschung Ludwigshafen |
| ClinicalTrials.gov Identifier: | NCT00372216 History of Changes |
| Other Study ID Numbers: | CIPAMI |
| Study First Received: | September 4, 2006 |
| Last Updated: | November 18, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
myocardial infarction Clopidogrel primary PCI TIMI-flow STEMI within 6 hrs. |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |