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

Condition(s) targeted: Myocardial Infarction

Intervention: Clopidogrel (Iscover/Plavix) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Stiftung Institut fuer Herzinfarktforschung

Official(s) and/or principal investigator(s):
Uwe Zeymer, MD, Principal Investigator, Affiliation: Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen Germany

Overall contact:
Uwe Zeymer, MD, Phone: +49 621-503-0, Email: ZeymerU@klilu.de

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

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: TIMI 2/3 patency of the infarct-related artery immediately prior to PCI

Secondary outcome:

TIMI 3 patency before PCI

TIMI 3 patency after PCI

ST resolution immediately before angiography and 60-90 minutes after PCI

Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge

Stroke (hemorrhagic, non-hemorrhagic)

Severe bleeding complications according to the TIMI classification

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Uwe Zeymer, MD, Phone: +49 621-503-0, Email: ZeymerU@klilu.de

DRK-Kliniken Westend, Berlin 14050, Germany; Recruiting
Ralph Schoeller, MD
Ralph Schoeller, MD, Principal Investigator

Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus, Berlin 10365, Germany; Recruiting
Sven Tessin, MD
Sven Tessin, MD, Principal Investigator

Universitaetsklinikum Benjamin Franklin, Berlin 12200, Germany; Recruiting
Hans-Richard Arntz, MD
Hans-Richard Arntz, MD, Principal Investigator

Vivantes Klinikum Neukoelln, Berlin 12351, Germany; Recruiting
Harald Darius, MD
Harald Darius, MD, Principal Investigator

Maria Heimsuchung / Caritas-Klinik Pankow, Berlin 13187, Germany; Recruiting
Heiko Lehmann, MD
Heiko Lehmann, MD, Principal Investigator

Staedtisches Klinikum, Brandenburg 14770, Germany; Recruiting
Michael Oeff, MD
Michael Oeff, MD, Principal Investigator

Universitaetsklinikum Mannheim, Mannheim, Baden-Wuerttemberg 68167, Germany; Recruiting
Juergen Meinhardt, MD
Juergen Meinhardt, MD, Principal Investigator

KMG-Kliniken AG / Klinikum Wittstock, Wittstock, Brandenburg 16909, Germany; Recruiting
Volker Hitz, MD
Volker Hitz, MD, Principal Investigator

Klinikum der Johann-Wolfgang-Goethe Universitaet, Frankfurt, Hessen 60590, Germany; Recruiting
Andreas Zeiher, MD
Andreas Zeiher, MD, Principal Investigator

St. Vincenz-Krankenhaus, Limburg, Hessen 65549, Germany; Recruiting
Joerg Kreuzer, MD
Joerg Kreuzer, MD, Principal Investigator

Kerckhoff Klinik, Bad Nauheim, Hessen 61231, Germany; Not yet recruiting
Thorsten Dill, MD
Thorsten Dill, MD, Principal Investigator

Universitaetsklinikum Giessen, Giessen, Hessen 35392, Germany; Not yet recruiting
Till Spiegl, MD
Ali Erdogan, MD, Principal Investigator

Kreiskrankenhaus Bergstrasse, Heppenheim, Hessen 64646, Germany; Not yet recruiting
Wolfgang Auch-Schwelk, MD
Wolfgang Auch-Schwelk, MD, Principal Investigator

Klinikum Darmstadt, Darmstadt, Hessen 64283, Germany; Not yet recruiting
Gerald Werner, MD
Gerald Werner, MD, Principal Investigator

Medizinische Hochschule, Hannover, Niedersachsen 30625, Germany; Not yet recruiting
Bernhard Schieffer, MD
Bernhard Schieffer, MD, Principal Investigator

Evangelisches Krankenhaus, Holzminden, Niedersachsen 37603, Germany; Not yet recruiting
Christian Beythien, MD
Christian Beythien, MD, Principal Investigator

Städtisches Klinikum, Lüneburg, Niedersachsen 21339, Germany; Not yet recruiting
Wolfram Kupper, MD
Wolfram Kupper, MD, Principal Investigator

Klinikum Leverkusen, Leverkusen, Nordrhein-Westfalen 51375, Germany; Recruiting
Peter Schwimmbeck, MD
Peter Schwimmbeck, MD, Principal Investigator

Klinikum der Stadt Ludwigshafen, Med. Klinik B, Ludwigshafen, Rheinland-Pfalz 67063, Germany; Recruiting
Bernd Mark, MD, Phone: +49 621-503-0, Email: MarkB@klilu.de
Bernd Mark, MD, Principal Investigator
Joerg Friedrich, MD, Sub-Investigator
Elke Fromm, MD, Sub-Investigator

Klinikum Saarbruecken, Saarbruecken, Saarland 66119, Germany; Recruiting
Heiner Krieter, MD
Heiner Krieter, MD, Principal Investigator

Universitaet Leipzig - Herzzentrum, Leipzig, Sachsen 04289, Germany; Recruiting
Holger Thiele, MD
Holger Thiele, MD, Principal Investigator

Starting date: October 2006
Ending date: December 2009
Last updated: September 17, 2009