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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 |
| Enrollment: | 338 |
| 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 |
|---|---|
|
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| Austria | |
| Wilhelminenspital | |
| Wien, Austria, A-1171 | |
| Universitaetsklinikum Innsbruck | |
| Innsbruck, Austria, A-6020 | |
| Hanusch-Krankenhaus | |
| Wien, Austria, A-1140 | |
| Germany | |
| Universitaetsklinikum Benjamin Franklin | |
| Berlin, Germany, 12200 | |
| Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus | |
| Berlin, Germany, 10365 | |
| DRK-Kliniken Westend | |
| Berlin, Germany, 14050 | |
| Vivantes Klinikum Neukoelln | |
| Berlin, Germany, 12351 | |
| Maria Heimsuchung / Caritas-Klinik Pankow | |
| Berlin, Germany, 13187 | |
| Staedtisches Klinikum | |
| Brandenburg, Germany, 14770 | |
| Germany, Baden-Wuerttemberg | |
| Universitaetsklinikum Mannheim | |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| Germany, Brandenburg | |
| KMG-Kliniken AG / Klinikum Wittstock | |
| Wittstock, Brandenburg, Germany, 16909 | |
| Germany, Hessen | |
| Klinikum der Johann-Wolfgang-Goethe Universitaet | |
| Frankfurt, Hessen, Germany, 60590 | |
| St. Vincenz-Krankenhaus | |
| Limburg, Hessen, Germany, 65549 | |
| Kerckhoff Klinik | |
| Bad Nauheim, Hessen, Germany, 61231 | |
| Universitaetsklinikum Giessen | |
| Giessen, Hessen, Germany, 35392 | |
| Kreiskrankenhaus Bergstrasse | |
| Heppenheim, Hessen, Germany, 64646 | |
| Klinikum Darmstadt | |
| Darmstadt, Hessen, Germany, 64283 | |
| Germany, Mecklenburg-Vorpommern | |
| Universitaetsklinikum Rostock | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18057 | |
| Germany, Niedersachsen | |
| Evangelisches Krankenhaus | |
| Holzminden, Niedersachsen, Germany, 37603 | |
| Städtisches Klinikum | |
| Lüneburg, Niedersachsen, Germany, 21339 | |
| Allgemeines Krankenhaus | |
| Celle, Niedersachsen, Germany, 29223 | |
| Germany, Nordrhein-Westfalen | |
| Klinikum Leverkusen | |
| Leverkusen, Nordrhein-Westfalen, Germany, 51375 | |
| Germany, Rheinland-Pfalz | |
| Klinikum der Stadt Ludwigshafen, Med. Klinik B | |
| Ludwigshafen, Rheinland-Pfalz, Germany, 67063 | |
| Germany, Saarland | |
| Klinikum Saarbruecken | |
| Saarbruecken, Saarland, Germany, 66119 | |
| Germany, Sachsen | |
| Universitaet Leipzig - Herzzentrum | |
| Leipzig, Sachsen, Germany, 04289 | |
| 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: | January 21, 2010 |
| 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 |