CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Clopidogrel (Iscover/Plavix)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute STEMI <= 6 hrs. Planned percutaneous coronary intervention Age >= 18 years Ability to understand the natures, scope, and possible consequences of the study / legal capacity Informed consent Exclusion Criteria: Thrombolytic therapy within 24 hours before randomization Effective oral or intravenous anticoagulation (INR>2, or PTT>2xcontrol) Known hemorrhagic diathesis Stroke or TIA within 3 months Evidence of an active gastrointestinal or urogenital bleeding Major surgery (including CABG) within 6 weeks Contraindication to Clopidogrel Severe renal or hepatic insufficiency Contraindication to coronary angiography Planned administration of a GP IIb/IIIa-Inhibitor before angiography Pregnant or nursing (lactating) women Women with childbearing potential Patients currently (within the last 10 days) treated with clopidogrel or ticlopidine Participation in another clinical or device trial within the previous 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy) | Drug: Clopidogrel (Iscover/Plavix)<br>* Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible<br>* Other names: Plavix 75 mg filmtablets;|
| No Intervention: 2<br>Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, Clopidogrel, primary PCI, TIMI-flow, STEMI within 6 hrs.