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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Sanofi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy) |
|
| 2 | No Intervention | Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel (Iscover/Plavix) | Drug | Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible |
|
| Measure | Description | Time Frame |
|---|---|---|
| TIMI 2/3 patency of the infarct-related artery immediately prior to PCI | Assessment at primary PCI, asap after inclusion of the subject |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI 3 patency before PCI | Assessment before primary PCI, asap after inclusion of the subject | |
| TIMI 3 patency after PCI | Assessment at primary PCI, asap after inclusion of the subject | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Zeymer, MD | Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Innsbruck | Innsbruck | A-6020 | Austria | |||
| Hanusch-Krankenhaus |
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| ST resolution immediately before angiography and 60-90 minutes after PCI |
| Assessment immediately before angiography until 90 minutes after PCI |
| Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge | Starting with inclusion of the subject until day 7 |
| Stroke (hemorrhagic, non-hemorrhagic) | Starting with inclusion of the subject until day 7 |
| Severe bleeding complications according to the TIMI classification | Starting with inclusion of the subject until day 7 |
| Vienna |
| A-1140 |
| Austria |
| Wilhelminenspital | Vienna | A-1171 | Austria |
| Universitaetsklinikum Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Staedtisches Klinikum | Brandenburg an der Havel | Brandenburg | 14770 | Germany |
| KMG-Kliniken AG / Klinikum Wittstock | Wittstock | Brandenburg | 16909 | Germany |
| Kerckhoff Klinik | Bad Nauheim | Hesse | 61231 | Germany |
| Klinikum Darmstadt | Darmstadt | Hesse | 64283 | Germany |
| Klinikum der Johann-Wolfgang-Goethe Universitaet | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Giessen | Giessen | Hesse | 35392 | Germany |
| Kreiskrankenhaus Bergstrasse | Heppenheim an der Bergstrasse | Hesse | 64646 | Germany |
| St. Vincenz-Krankenhaus | Limburg an der Lahn | Hesse | 65549 | Germany |
| Allgemeines Krankenhaus | Celle | Lower Saxony | 29223 | Germany |
| Evangelisches Krankenhaus | Holzminden | Lower Saxony | 37603 | Germany |
| Städtisches Klinikum | Lüneburg | Lower Saxony | 21339 | Germany |
| Universitaetsklinikum Rostock | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Klinikum Leverkusen | Leverkusen | North Rhine-Westphalia | 51375 | Germany |
| Klinikum der Stadt Ludwigshafen, Med. Klinik B | Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| Klinikum Saarbruecken | Saarbrücken | Saarland | 66119 | Germany |
| Universitaet Leipzig - Herzzentrum | Leipzig | Saxony | 04289 | Germany |
| Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus | Berlin | State of Berlin | 10365 | Germany |
| Universitaetsklinikum Benjamin Franklin | Berlin | State of Berlin | 12200 | Germany |
| Vivantes Klinikum Neukoelln | Berlin | State of Berlin | 12351 | Germany |
| Maria Heimsuchung / Caritas-Klinik Pankow | Berlin | State of Berlin | 13187 | Germany |
| DRK-Kliniken Westend | Berlin | State of Berlin | 14050 | Germany |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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