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

Phase 3

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Clopidogrel (Iscover/Plavix)

• Registration Number: NCT00372216
• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2006-09-04
• Study First Submitted QC: 2006-09-04
• Study First Posted: 2006-09-06
• Study Start: 2006-10
• Primary Completion: 2009-10
• Study Completion: 2010-01
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clopidogrel (Iscover/Plavix)	Pre-hospital loading dose of 600 mg Clopidogrel as early as possible (in addition to standard infarction therapy)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (25)

KMG-Kliniken AG / Klinikum Wittstock; 🇩🇪 Wittstock, Brandenburg, Germany

Klinikum Saarbruecken; 🇩🇪 Saarbruecken, Saarland, Germany

Universitaetsklinikum Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

Klinikum Leverkusen; 🇩🇪 Leverkusen, Nordrhein-Westfalen, Germany

Hanusch-Krankenhaus; 🇦🇹 Wien, Austria

Wilhelminenspital; 🇦🇹 Wien, Austria

Universitaetsklinikum Innsbruck; 🇦🇹 Innsbruck, Austria

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Hessen, Germany

Klinikum Darmstadt; 🇩🇪 Darmstadt, Hessen, Germany

Universitaetsklinikum Mannheim; 🇩🇪 Mannheim, Baden-Wuerttemberg, Germany

Klinikum der Johann-Wolfgang-Goethe Universitaet; 🇩🇪 Frankfurt, Hessen, Germany

Universitaetsklinikum Giessen; 🇩🇪 Giessen, Hessen, Germany

Kreiskrankenhaus Bergstrasse; 🇩🇪 Heppenheim, Hessen, Germany

St. Vincenz-Krankenhaus; 🇩🇪 Limburg, Hessen, Germany

Städtisches Klinikum; 🇩🇪 Lüneburg, Niedersachsen, Germany

Evangelisches Krankenhaus; 🇩🇪 Holzminden, Niedersachsen, Germany

Allgemeines Krankenhaus; 🇩🇪 Celle, Niedersachsen, Germany

Klinikum der Stadt Ludwigshafen, Med. Klinik B; 🇩🇪 Ludwigshafen, Rheinland-Pfalz, Germany

Universitaetsklinikum Benjamin Franklin; 🇩🇪 Berlin, Germany

Maria Heimsuchung / Caritas-Klinik Pankow; 🇩🇪 Berlin, Germany

Universitaet Leipzig - Herzzentrum; 🇩🇪 Leipzig, Sachsen, Germany

Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus; 🇩🇪 Berlin, Germany

Vivantes Klinikum Neukoelln; 🇩🇪 Berlin, Germany

DRK-Kliniken Westend; 🇩🇪 Berlin, Germany

Staedtisches Klinikum; 🇩🇪 Brandenburg, Germany