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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-01-31

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.

Detailed Description

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Conditions

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Myocardial Infarction

Keywords

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myocardial infarction Clopidogrel primary PCI TIMI-flow STEMI within 6 hrs.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)

Group Type ACTIVE_COMPARATOR

Clopidogrel (Iscover/Plavix)

Intervention Type DRUG

Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible

2

Standard infarction therapy (without study-specific additions, no Clopidogrel before angiography)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clopidogrel (Iscover/Plavix)

Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible

Intervention Type DRUG

Other Intervention Names

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Iscover 75 mg filmtablets Plavix 75 mg filmtablets

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Stiftung Institut fuer Herzinfarktforschung Ludwigshafen

Principal Investigators

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Uwe Zeymer, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany

Locations

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Universitaetsklinikum Innsbruck

Innsbruck, , Austria

Site Status

Hanusch-Krankenhaus

Vienna, , Austria

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Wilhelminenspital

Vienna, , Austria

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Universitaetsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

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Staedtisches Klinikum

Brandenburg, Brandenburg, Germany

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KMG-Kliniken AG / Klinikum Wittstock

Wittstock, Brandenburg, Germany

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Kerckhoff Klinik

Bad Nauheim, Hesse, Germany

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Klinikum Darmstadt

Darmstadt, Hesse, Germany

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Klinikum der Johann-Wolfgang-Goethe Universitaet

Frankfurt am Main, Hesse, Germany

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Universitaetsklinikum Giessen

Giessen, Hesse, Germany

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Kreiskrankenhaus Bergstrasse

Heppenheim an der Bergstrasse, Hesse, Germany

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St. Vincenz-Krankenhaus

Limburg an der Lahn, Hesse, Germany

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Allgemeines Krankenhaus

Celle, Lower Saxony, Germany

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Evangelisches Krankenhaus

Holzminden, Lower Saxony, Germany

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Städtisches Klinikum

Lüneburg, Lower Saxony, Germany

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Universitaetsklinikum Rostock

Rostock, Mecklenburg-Vorpommern, Germany

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Klinikum Leverkusen

Leverkusen, North Rhine-Westphalia, Germany

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Klinikum der Stadt Ludwigshafen, Med. Klinik B

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

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Klinikum Saarbruecken

Saarbrücken, Saarland, Germany

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