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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372216
• Other study ID #: CIPAMI
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2006
• Last updated: November 18, 2010
• Start date: October 2006
• Est. completion date: January 2010

Study information

• Verified date: November 2010
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Clopidogrel (Iscover/Plavix)
Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible

Locations

Country	Name	City	State
Austria	Universitaetsklinikum Innsbruck	Innsbruck
Austria	Hanusch-Krankenhaus	Wien
Austria	Wilhelminenspital	Wien
Germany	Kerckhoff Klinik	Bad Nauheim	Hessen
Germany	DRK-Kliniken Westend	Berlin
Germany	Maria Heimsuchung / Caritas-Klinik Pankow	Berlin
Germany	Sana Klinikum Lichtenberg / Oskar-Ziethen-Krankenhaus	Berlin
Germany	Universitaetsklinikum Benjamin Franklin	Berlin
Germany	Vivantes Klinikum Neukoelln	Berlin
Germany	Staedtisches Klinikum	Brandenburg
Germany	Allgemeines Krankenhaus	Celle	Niedersachsen
Germany	Klinikum Darmstadt	Darmstadt	Hessen
Germany	Klinikum der Johann-Wolfgang-Goethe Universitaet	Frankfurt	Hessen
Germany	Universitaetsklinikum Giessen	Giessen	Hessen
Germany	Kreiskrankenhaus Bergstrasse	Heppenheim	Hessen
Germany	Evangelisches Krankenhaus	Holzminden	Niedersachsen
Germany	Universitaet Leipzig - Herzzentrum	Leipzig	Sachsen
Germany	Klinikum Leverkusen	Leverkusen	Nordrhein-Westfalen
Germany	St. Vincenz-Krankenhaus	Limburg	Hessen
Germany	Klinikum der Stadt Ludwigshafen, Med. Klinik B	Ludwigshafen	Rheinland-Pfalz
Germany	Städtisches Klinikum	Lüneburg	Niedersachsen
Germany	Universitaetsklinikum Mannheim	Mannheim	Baden-Wuerttemberg
Germany	Universitaetsklinikum Rostock	Rostock	Mecklenburg-Vorpommern
Germany	Klinikum Saarbruecken	Saarbruecken	Saarland
Germany	KMG-Kliniken AG / Klinikum Wittstock	Wittstock	Brandenburg

Sponsors (3)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Bristol-Myers Squibb, Sanofi

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI 2/3 patency of the infarct-related artery immediately prior to PCI		Assessment at primary PCI, asap after inclusion of the subject	No
Secondary	TIMI 3 patency before PCI		Assessment before primary PCI, asap after inclusion of the subject	No
Secondary	TIMI 3 patency after PCI		Assessment at primary PCI, asap after inclusion of the subject	No
Secondary	ST resolution immediately before angiography and 60-90 minutes after PCI		Assessment immediately before angiography until 90 minutes after PCI	No
Secondary	Death, re-MI, urgent revascularisation until 48 hours and until hospital discharge		Starting with inclusion of the subject until day 7	Yes
Secondary	Stroke (hemorrhagic, non-hemorrhagic)		Starting with inclusion of the subject until day 7	Yes
Secondary	Severe bleeding complications according to the TIMI classification		Starting with inclusion of the subject until day 7	Yes